This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the hylaform. 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 (HYLAN B GEL) |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | GENZYME BIOSURGERY |
| Date Received | 2003-08-01 |
| Decision Date | 2004-04-22 |
| Notice Date | 2004-05-05 |
| PMA | P030032 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 04M-0199 |
| Advisory Committee | General & Plastic Surgery |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| 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 |