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 changes to the quality control test methods.
| Device | PREVELLE SILK |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | GENZYME BIOSURGERY |
| Date Received | 2013-09-25 |
| Decision Date | 2014-08-06 |
| PMA | P030032 |
| Supplement | S016 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | GENZYME BIOSURGERY 55 Cambridge Parkway cambridge, MA 02142 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030032 | Original Filing | |
| S017 | 2014-08-08 | 30-day Notice |
| S016 | 2013-09-25 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2011-12-20 | 135 Review Track For 30-day Notice |
| S013 | 2011-09-02 | 30-day Notice |
| S012 | 2011-05-27 | Real-time Process |
| S011 | ||
| S010 | 2010-06-09 | 135 Review Track For 30-day Notice |
| S009 | 2009-09-11 | 30-day Notice |
| S008 | 2009-04-15 | Normal 180 Day Track No User Fee |
| S007 | 2007-07-25 | Normal 180 Day Track |
| S006 | ||
| S005 | 2006-01-27 | Normal 180 Day Track No User Fee |
| S004 | 2005-09-23 | Real-time Process |
| S003 | 2005-04-20 | Normal 180 Day Track No User Fee |
| S002 | 2004-07-28 | Normal 180 Day Track |
| S001 | 2004-06-22 | Panel Track |