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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, nonabsorbable, synthetic, polyethylene
Generic Namepronova* nonabsorbable suture, usp
Regulation Number878.5000
ApplicantETHICON, INC.
PMA NumberN16374
Supplement NumberS036
Date Received12/21/1998
Decision Date06/24/1999
Product Code
GAT[ Registered Establishments with GAT ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pronova non-absorbable suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene). The device, as modified, will be marketed under the trade name pronova and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.