This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | 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 |
| PMA | N16420 |
| Supplement | S001 |
| Product Code | LTG |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N16420 | Original Filing | |
| S007 | 2004-12-09 | 30-day Notice |
| S006 | 2001-10-26 | Normal 180 Day Track |
| S005 | 2000-12-26 | Normal 180 Day Track |
| S004 | 1992-12-24 | Normal 180 Day Track |
| S003 | ||
| S002 | ||
| S001 | 1983-05-23 | Normal 180 Day Track |