MERSILENE*POLYESTER SUTURE
FDA premarket approval N12815/S023 · decided 1988-12-22
Approval details
- PMA number
- N12815
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MERSILENE*POLYESTER SUTURE
- Generic name
- Suture, nonabsorbable
- Applicant
- ETHICON, Inc.
- Date received
- 1988-02-16
- Decision date
- 1988-12-22
- Days to decision
- 310 days
- Decision code
- APPR
- Product code
- GAO
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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