MENTOR POLYTEF PASTE FOR INJECTION
FDA premarket approval N16420/S001 · decided 1983-12-20
Approval details
- PMA number
- N16420
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- MENTOR POLYTEF PASTE FOR INJECTION
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Applicant
- Coloplast Corp.
- Date received
- 1983-05-23
- Decision date
- 1983-12-20
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LTG
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Plymouth, MN
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|---|---|---|
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