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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRONOVA ABSORABLE SUTURE, USP
Generic NameSuture, nonabsorbable, synthetic, polyethylene
Regulation Number878.5000
ApplicantETHICON, Inc.
Rte. 22 W.
Somerville, NJ 08876
PMA NumberN16374
Supplement NumberS036
Date Received12/21/1998
Decision Date06/24/1999
Product Code GAT 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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