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2009 Exhibit: Ex 2009 61 Fed Reg 52,602 10796

Document IPR2020-00152, No. 2009 Exhibit - Ex 2009 61 Fed Reg 52,602 10796 (P.T.A.B. Jul. 22, 2020)
The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use.
Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for the methods used in, and the facilities and controls used for the manufacture, packing, storage, and installation of medical devices.
The Supreme Court recently addressed the preemptive effect, under section 521 of the act (21 U.S.C. 360k), of the original CGMP regulation and other FDA requirements for medical devices on State tort actions.
The extent of the documentation necessary to meet the regulation requirements may vary with the complexity of the design and manufacturing operations, the size of the firm, the importance of a process, and the risk associated with the failure of the device, among other factors.
Because of a number of competitive and other issues, including sharply divided views by members of the GMP Advisory Committee at the September 1995 meeting, FDA has elected to address application of the CGMP requirements to persons who perform servicing and refurbishing functions outside the control of the original manufacturer in a separate rulemaking later this year, with another opportunity for public comment.
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2017 Exhibit: Ex 2017 510k Premarket Notification No K920752, Ethicon

Document IPR2020-00152, No. 2017 Exhibit - Ex 2017 510k Premarket Notification No K920752, Ethicon (P.T.A.B. Jul. 22, 2020)
/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=GDW Page Last Updated: 07/13/2020 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
| Kreyòl | Ting Vit | | Tagalog | | Language Assistance Available: Español | | | English Ayisyen | Français | Polski | Português | Italiano | Deutsch | Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph.
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2010 Exhibit: Ex 2010 Excerpted File History for US7954683 Knodel

Document IPR2020-00152, No. 2010 Exhibit - Ex 2010 Excerpted File History for US7954683 Knodel (P.T.A.B. Jul. 22, 2020)
al. Cardica, Inc. Feeder Belt with Integrated Surgical Staples 11/956,988 Filing Date: Lindsay M. Low Group Art Unit: December 14, 2007 3721 January 28, 2011 Commissioner for Patents P.O.
al. Cardica, Inc. Feeder Belt with Integrated Surgical Staples 11/956,988 Filing Date: Lindsay M. Low Group Art Unit: December 14, 2007 3721
In contrast, U.S. Pat. No. 6,391,038 describes staples connected to only a single lateral edge of a backbone 66, as acknowledged by the annotated Figure 10A from Vargas on page 6 of the Office Action.
Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term adjustment.
Application/Control Number: 11/956,988 Art Unit: 3721 Page 8 Regarding claim 5, the modified row of staples is frangibly connected along a line located betweenthe lateral edges of the feeder belt (see Fig. 3 of Green).
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2016 Exhibit: Ex 2016 510k Premarket Notification No K983536, Ethicon Endo Surgery

Document IPR2020-00152, No. 2016 Exhibit - Ex 2016 510k Premarket Notification No K983536, Ethicon Endo Surgery (P.T.A.B. Jul. 22, 2020)
/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&knumber=K983536 Page Last Updated: 07/13/2020 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
| Kreyòl | Ting Vit | | Tagalog | | Language Assistance Available: Español | Ayisyen | Français | Polski | Português | Italiano | Deutsch | | | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph.
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1009 Exhibit: US Pat No 5,507,426 to Young et al

Document IPR2020-00152, No. 1009 Exhibit - US Pat No 5,507,426 to Young et al (P.T.A.B. Nov. 19, 2019)
Inventors: Wayne P. Young, Brewster, N.Y.; Daniel E. Alesi, Sherman; Kenneth E. Toso, Wilton, both of Conn. Assignee: United States Surgical Corporation, Norwalk, Conn. .
In some instru- includes an actuator which is configured to progressively ments a knife is provided to cut the tissue which has been movethe anvil member from the open position to the closed joined by the fasteners.
The distal ends of each ofthe firing bars includes a wedged cam surface 78 which engages staple pushers 35 as actuation mechanism 50 translates through fastener applying assem- bly 16.
The leading edge of support beam 52 defines a cutting blade 80 whichis configured to form an incision in the tissue located between the parallel rows of staples applied by assembly 16.
Although the subject apparatus has been described with respect to preferred embodiments, it will be readily apparent to those having ordinary skill in the art to which it appertains that changes and modifications may be made thereto without departing from the spirit or scope as defined by the appended claims.
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1005 Exhibit: US Pat No 4,429,695 to Green et al

Document IPR2020-00152, No. 1005 Exhibit - US Pat No 4,429,695 to Green et al (P.T.A.B. Nov. 19, 2019)

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1021 Exhibit: US Pat App Pub No 20060175375 Shelton 375

Document IPR2020-00152, No. 1021 Exhibit - US Pat App Pub No 20060175375 Shelton 375 (P.T.A.B. Oct. 28, 2020)

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1002 Exhibit: File history of the 650 Patent

Document IPR2020-00152, No. 1002 Exhibit - File history of the 650 Patent (P.T.A.B. Nov. 19, 2019)

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1004 Exhibit: US Pat No 5,645,209 to Green et al

Document IPR2020-00152, No. 1004 Exhibit - US Pat No 5,645,209 to Green et al (P.T.A.B. Nov. 19, 2019)

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1014 Exhibit: US Pat No 5,389,098 to Tsuruta et al

Document IPR2020-00152, No. 1014 Exhibit - US Pat No 5,389,098 to Tsuruta et al (P.T.A.B. Nov. 19, 2019)

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2001 Exhibit: Ex 2001 IPR2020 00152 Dolgin Declaration refiled as exhibit

Document IPR2020-00152, No. 2001 Exhibit - Ex 2001 IPR2020 00152 Dolgin Declaration refiled as exhibit (P.T.A.B. Feb. 24, 2020)

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1011 Exhibit: US Pat No 5,865,361 to Milliman et al

Document IPR2020-00152, No. 1011 Exhibit - US Pat No 5,865,361 to Milliman et al (P.T.A.B. Nov. 19, 2019)

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1007 Exhibit: US Pat No 4,605,001 to Rothfuss et al

Document IPR2020-00152, No. 1007 Exhibit - US Pat No 4,605,001 to Rothfuss et al (P.T.A.B. Nov. 19, 2019)

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1006 Exhibit: US Pat No 5,465,895 to Knodel et al

Document IPR2020-00152, No. 1006 Exhibit - US Pat No 5,465,895 to Knodel et al (P.T.A.B. Nov. 19, 2019)

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1008 Exhibit: US Pat No 5,954,259 to Viola et al

Document IPR2020-00152, No. 1008 Exhibit - US Pat No 5,954,259 to Viola et al (P.T.A.B. Nov. 19, 2019)

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