PREVELLE SILK
FDA premarket approval P030032/S007 · decided 2008-02-26
Approval details
- PMA number
- P030032
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PREVELLE SILK
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Genzyme Biosurgery
- Date received
- 2007-07-25
- Decision date
- 2008-02-26
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE ADDITION OF PHOSPHATE BUFFERED SALINE (PBS) AND LIDOCAINE HYDROCHLORIDE (HCL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELLE SILK AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
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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 |