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.
Approval for relocation of the formulation of the bulk paste and the equipment and processes associated with compounding to mentor, mineapolis, minnisota.
| Device | MENTOR POLYTEF PASTE /FOR INJECTION |
| Generic Name | Paste, Injectable For Vocal Cord Augmentation |
| Applicant | COLOPLAST CORP. |
| Date Received | 2001-10-26 |
| Decision Date | 2001-11-21 |
| PMA | N16420 |
| Supplement | S006 |
| Product Code | LTG |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |