ETHILON/NUROLON NYLON SUTURES
FDA premarket approval N85316/S011 · decided 1984-07-11
Approval details
- PMA number
- N85316
- Supplement
- S011
- Trade name
- ETHILON/NUROLON NYLON SUTURES
- Generic name
- Suture, nonabsorbable, synthetic, polyamide
- Applicant
- ETHICON, Inc.
- Date received
- 1984-06-04
- Decision date
- 1984-07-11
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- GAR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.