MENTOR POLYTEF PASTE FOR INJECTION
FDA premarket approval N16420/S007 · decided 2005-01-03
Approval details
- PMA number
- N16420
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR POLYTEF PASTE FOR INJECTION
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Applicant
- Coloplast Corp.
- Date received
- 2004-12-09
- Decision date
- 2005-01-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LTG
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| Luja Coudé (K251116) | Coloplast Corp. | 2025-06-27 |
| Luja Set (K250270) | Coloplast Corp. | 2025-04-17 |
| SureCath Set (K242049) | Coloplast Corp. | 2024-11-26 |
| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173) | Coloplast Corp. | 2024-11-12 |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |