PMA N16374S036

Device: PRONOVA ABSORABLE SUTURE, USP
Applicant: ETHICON, Inc.
PMA number: N16374
Supplement: S036
Product code: GAT
Decision date: 1999-06-24
Generic name: Suture, nonabsorbable, synthetic, polyethylene
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.

Current openFDA PMA Record#

Device: PRONOVA ABSORABLE SUTURE, USP
Applicant: ETHICON, Inc.
PMA number: N16374
Supplement: S036
Product code: GAT
Generic name: Suture, nonabsorbable, synthetic, polyethylene
Decision date: 1999-06-24
Decision code: APPR
Date received: 1998-12-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.