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 in the methods and specifications for testing the prevelle silk final product (i. E. , 1) changing the average extrusion force specificationfrom less than 80n to an average of average extrusion force specification of less than 40n, 2) changing the maximum peak extrusion force specification of less than 100n to an average of maximum peak extrusion force" specification of less than 50n and 3) changing the method of determining the maximum peak extrusion force specification from the highest single value observed in 10 samples to an average of the maximum peak extrusion force test results observed in 25 samples).
| Device | HYLAFORM (HYLAN B GEL); PREVELLE SILK |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | GENZYME BIOSURGERY |
| Date Received | 2011-05-27 |
| Decision Date | 2011-07-18 |
| PMA | P030032 |
| Supplement | S012 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |