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 an extension of the hylaform and hylaform plus shelf life from 24 to 36 months.
| Device | HYLAFORM AND HYLAFORM PLUS |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | GENZYME BIOSURGERY |
| Date Received | 2005-09-23 |
| Decision Date | 2005-11-02 |
| PMA | P030032 |
| Supplement | S004 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| 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 |