PREVELLE SILK
FDA premarket approval P030032/S017 · decided 2014-09-05
Approval details
- PMA number
- P030032
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PREVELLE SILK
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Genzyme Biosurgery
- Date received
- 2014-08-08
- Decision date
- 2014-09-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- ADDITION OF ENDOTOXIN TESTING TO THE PURIFIED WATER RAW MATERIAL SPECIFICATION.
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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 |