PRONOVA ABSORABLE SUTURE, USP
FDA premarket approval N16374/S036 · decided 1999-06-24
Approval details
- PMA number
- N16374
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRONOVA ABSORABLE SUTURE, USP
- Generic name
- Suture, nonabsorbable, synthetic, polyethylene
- Applicant
- ETHICON, Inc.
- Date received
- 1998-12-21
- Decision date
- 1999-06-24
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- GAT
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- 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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