HYLAFORM (HYLAN B GEL); PREVELLE SILK
FDA premarket approval P030032/S012 · decided 2011-07-18
Approval details
- PMA number
- P030032
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYLAFORM (HYLAN B GEL); PREVELLE SILK
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Genzyme Biosurgery
- Date received
- 2011-05-27
- Decision date
- 2011-07-18
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR CHANGES IN THE METHODS AND SPECIFICATIONS FOR TESTING THE PREVELLE SILK FINAL PRODUCT (I.E., 1) CHANGING THE AVERAGE EXTRUSION FORCE SPECIFICATIONFROM LESS THAN 80N TO AN AVERAGE OF AVERAGE EXTRUSION FORCE SPECIFICATION OF LESS THAN 40N, 2) CHANGING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION OF LESS THAN 100N TO AN AVERAGE OF MAXIMUM PEAK EXTRUSION FORCE" SPECIFICATION OF LESS THAN 50N AND 3) CHANGING THE METHOD OF DETERMINING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION FROM
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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 |