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 a manufacturing site located at mentor corporation, minneapolis, mn, and approval for two sterilization sites located at steris isomedix, inc. , minneapolis, mn, and biotest laboratories, inc. , minneapolis, mn.
| Device | POLYTEF PASTE FOR INJECTION |
| Generic Name | Paste, Injectable For Vocal Cord Augmentation |
| Applicant | COLOPLAST CORP. |
| Date Received | 2000-12-26 |
| Decision Date | 2001-05-30 |
| PMA | N16420 |
| Supplement | S005 |
| 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 |