HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE
FDA premarket approval P030032/S003 · decided 2005-07-01
Approval details
- PMA number
- P030032
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Genzyme Biosurgery
- Date received
- 2005-04-20
- Decision date
- 2005-07-01
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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 |