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No. 45-10 AMENDED COMPLAINT against Covidien, Inc., Tyco Healthcare Group LP, filed by Ethicon Endo-Surgery, ...

Document Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 1:11-cv-00871, No. 45-10 (S.D.Ohio Jun. 13, 2012)
Intended Use The Sonicision TM Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
These evaluations consisted of formative (verification) and sumnmative (validation) studies, which demonstrate the Sonicision device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.
I'Lblic HeIalth Sorvice Foo and Drug Adminisiaion 1 0903 Ne" I1 amps1ire Avenue Document Contiol Room -\%066-G609 Silver Spring-, Nil) 20993-0002 Covidien, formerly Vaileylab, Division of T'yco Healthcare %/ Mr. David NM.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic struictures (such as spine and joint space) and other open and endoscbpic procedures.
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