/"]#
`
`( , , .~ DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Room W-O66-0609
`Silver Spring, MD 20993-0002
`
`Allergan
`% Amy Tezel, PhD
`Manager, Regulatory Affairs
`71 South Los Cameras Roact
`Goleta, California 93117
`
`JAN - 7 2010
`
`Re:
`
`P050047/S005
`Juvederm Ultra XC and Juvederm Ultra Plus XC
`Filed: August 18, 2008
`Amended: January 27, 2009, July 29, 2009 and November 18, 2009
`
`Dear Dr. Tezel:
`
`The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
`(FDA) has completed its evaluation of your premarket approval application (PMA) supplement,
`which requested approval for the addition of 0.3% lidocaine into Juvederm Ultra and Juvederm
`Ultra Plus. The device, as modified, will be marketed under the trade name Juvederm Ultra XC
`and Juvederm Ultra Plus XC and is indicated for injectior. into the mid to deep dermis for
`correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Based upon
`the information submitted, the PMA supplement is approved. You may begin commercial
`distribution of the device as modified by your PMA supplement in accordance with the
`conditions described below.
`
`The sale and distribution of this device are restricted to prescription use in accordance with 21
`CFR 801.109 and under section 515(d)(l)(B)(ii) of the Federal Food, Drug, and Cosmetic Act
`(the act). FDA has determined that this restriction on sale and distribution is necessary to
`provide reasonable assurance of the safety and effectiveness of the device. Your device is
`therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in
`addition to the many other FDA requirements governing the manufacture, distribution, and
`marketing of devices.
`
`Expiration dating for this device has been established and approved at 12 months stored at USP
`controlled temperature (25°C with excursions permitted to l 5°C-30°C).
`
`Continued approval of this PMA is contingent upon the submission of periodic reports, required
`under 21 CFR 814.84, at intervals of one year (unless otherwise specified) from the date of
`approval of the original PMA. Two copies of this report, identified as "Annual Report" (please
`use this title even if the specified interval is more frequent than one year) and bearing the
`applicable PMA reference number, should be submitted to the address below. The Annual
`Report should indicate the beginning and ending date of the period covered by the report and
`should include the information required by 21 CFR 814.84.
`
`Exhibit 1077
`Prollenium v. Allergan
`
`

`

`Page 2 - Amy Tezel, PhD
`
`In addition to the above, and in order to provide continued reasonable assurance of the safety and
`effectiveness of the device, the Annual Report must include, separately for each model number
`(if applicable), the number of devices sold and distributed during the reporting period, including
`those distributed to distributors. The distribution data will serve as a denominator and provide
`necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA
`evaluates the continued safety and effectiveness of the device.
`
`Before making any change affecting the safety or effectiveness of the device, you must submit a
`PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39.
`All PMA supplements and alternate submissions (30-day notice) must comply with the
`applicable requirements in 21 CFR 814.39. For more information, please refer to the FDA
`guidance document entitled, "Modifications to Devices Subject to Premarket Approval (PMA) -
`The PMA Supplement Decision-Making Process"
`(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274
`.htm).
`
`You are reminded that many FDA requirements govern the manufacture, distribution, and
`marketing of devices. For example, in accordance with the Medical Device Reporting (MDR)
`regulation, 21 CFR 803.50 and 21 CFR 803.52, you are required to report adverse events for this
`device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to
`report to FDA no later than 30 calendar days after the day they receive or otherwise becomes
`aware of information, from any source, that reasonably suggests that one of their marketed
`devices:
`
`I. May have caused or contributed to a death or serious injury; or
`
`2.
`
`Has malfunctioned and such device or similar device marketed by the manufacturer
`would be likely to cause or contribute to a death or serious injury if the malfunction
`were to recur.
`
`Additional information on MDR, including how, when, and where to report, is available at
`www.faa.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
`
`In accordance with the recall requirements specified in 21 CFR 806.10, you are required to
`submit a written report to FDA of any correction or removal of this device initiated by you to:
`(I) reduce a risk to health posed by the device; or (2) remedy a violation of the act caused by the
`device which may present a risk to health, with certain exceptions specified in 21 CFR
`806. l 0(a)(2). Additional information on recalls is available at
`www.fda.gov/Safety/Recalls/lndustryGuidance/default.htm.
`
`CDRH does not evaluate information related to contract liability warranties. We remind you;
`however, that device labeling must be truthful and not misleading. CDRH will notify the public
`of its decision to approve your PMA by making available, among other information, a summary
`
`

`

`Page 3 - Amy Tezel, PhD
`
`of the safety and effectiveness data upon which the approval is based. The information can be
`found on the FDA CDRH Internet HomePage located at
`www. f <la.gov /Medical Devices/ProductsandMedical Procedures/DeviceApprovalsandClearances/
`PMAApprovals/default.htm. Written requests for this information can also be made to the
`Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
`Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or
`docket number. Within 30 days from the date that this information is placed on the Internet, any
`interested person may seek review of this decision by submitting a petition for review under
`section 5 l 5(g) of the act and requesting either a hearing or review by an independent advisory
`committee. FDA may, for good cause, extend this 30-day filing period.
`
`Failure to comply with any post-approval requirement constitutes a ground for withdrawal of
`approval of a PMA. The introduction or delivery for introduction into interstate commerce of a
`device that is not in compliance with its conditions of approval is a violation of law.
`
`You are reminded that, as soon as possible and before commercial distribution of your device,
`you must submit an amendment to this PMA submission with copies of all approved labeling in
`final printed form. Final printed labeling that is identical to the labeling approved in draft form
`will not routinely be reviewed by FDA staff when accompanied by a cover letter stating that the
`final printed labeling is identical to the labeling approved in draft form. If the final printed
`labeling is not identical, any changes from the final draft labeling should be highlighted and
`explained in the amendment.
`
`All required documents should be submitted in triplicate, unless otherwise specified, to the
`address below and should reference the above PMA number to facilitate processing. One of
`those three copies may be an electronic copy ( eCopy), in an electronic format that FDA can
`process, review and archive (general information:
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/P
`remarketSubmissions/ucm 134508.htm; clinical and statistical data:
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/P
`remarketSubmissions/ucm 1363 77 .htm )
`
`U.S. Food and Drug Administration
`Center for Devices and Radiological Health
`PMA Document Mail Center - WO66-G609
`l 0903 New Hampshire A venue
`Silver Spring, MD 20993-0002
`
`

`

`Page 4 - Amy Tezel, PhD
`
`If you have questions concerning this approval order, please contact
`
`(b)(6)
`
`(b)(6)
`
`Sincerelv.. vo~.
`
`(b)(6)
`
`Mark N. Melkerson
`Director
`Division of Surgical, Orthopedic
`and Restorative Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`