PDS SUTURE (DYED)
FDA premarket approval N18331/S020 · decided 1987-10-05
Approval details
- PMA number
- N18331
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PDS SUTURE (DYED)
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Applicant
- ETHICON, Inc.
- Date received
- 1987-09-01
- Decision date
- 1987-10-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NEW
- 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.