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Intracardiac Patch Or Pledget, Biologically Derived

FDA product code PSQ · 11 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.3470
Review panel
CV
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-28 – 2022-10-19

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

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