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 the hylaform plus. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
| Device | HYLAFORM PLUS (HYLAN B GEL) |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | GENZYME BIOSURGERY |
| Date Received | 2004-06-22 |
| Decision Date | 2004-10-13 |
| Notice Date | 2004-10-27 |
| PMA | P030032 |
| Supplement | S001 |
| Product Code | LMH |
| Docket Number | 04M-0467 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME BIOSURGERY 55 Cambridge Parkway cambridge, MA 02142 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |