HYLAFORM (HYLAN B GEL)
FDA premarket approval P030032 · decided 2004-04-22
Approval details
- PMA number
- P030032
- Trade name
- HYLAFORM (HYLAN B GEL)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Genzyme Biosurgery
- Date received
- 2003-08-01
- Decision date
- 2004-04-22
- Days to decision
- 265 days
- Decision code
- APWD
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- 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).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K031554) | Genzyme Biosurgery | 2003-07-25 |
| MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K030212) | Genzyme Biosurgery | 2003-03-27 |
| RADLITE TISSUE RETRACTOR SYSTEM (K022989) | Genzyme Biosurgery | 2002-11-25 |
| SAPH-LOOP LIGATING LOOP (K022410) | Genzyme Biosurgery | 2002-08-20 |