EVOLENCE COLLAGEN FILLER
FDA premarket approval P070013/S003 · decided 2009-06-05
Approval details
- PMA number
- P070013
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EVOLENCE COLLAGEN FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Colbar Lifescience , Ltd.
- Date received
- 2008-08-28
- Decision date
- 2009-06-05
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Herzliya
- Statement
- APPROVAL FOR LABELING CHANGES BASED ON THE ADDITIONAL CLINICAL 12 MONTH SAFETY AND EFFICACY DATA SUBMITTED TO EXTEND THE INITIAL 6 MONTH SAFETY AND EFFICACY DATA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OSSIX -PLUS (K053260) | Colbar Lifescience , Ltd. | 2006-02-22 |