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Pericardial Patch To Facilitate Revision Surgeries

FDA product code OMH · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.3470
Review panel
CV
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2003-09-04 – 2003-09-04

Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.

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