This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | MENTOR POLYTEF PASTE FOR INJECTION |
| Generic Name | Paste, Injectable For Vocal Cord Augmentation |
| Applicant | COLOPLAST CORP. |
| Date Received | 1972-01-20 |
| Decision Date | 1972-01-20 |
| PMA | N16420 |
| Supplement | S |
| Product Code | LTG |
| Advisory Committee | Dental |
| 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 |