POLYTEF PASTE FOR VOCAL CORD INJECTION
FDA premarket approval N16420/S004 · decided 1993-12-08
Approval details
- PMA number
- N16420
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYTEF PASTE FOR VOCAL CORD INJECTION
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Applicant
- Coloplast Corp.
- Date received
- 1992-12-24
- Decision date
- 1993-12-08
- Days to decision
- 349 days
- Decision code
- APPR
- Product code
- LTG
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Plymouth, MN
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510(k) clearances by this applicant
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|---|---|---|
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| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
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| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |