EVOLENCE COLLAGEN DERMAL FILLER
FDA premarket approval P070013/S001 · decided 2008-08-14
Approval details
- PMA number
- P070013
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVOLENCE COLLAGEN DERMAL FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Colbar Lifescience , Ltd.
- Date received
- 2008-06-30
- Decision date
- 2008-08-14
- Days to decision
- 45 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Herzliya
- Statement
- INCREASE IN PRODUCTION CAPACITY FOR THE DEVICE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OSSIX -PLUS (K053260) | Colbar Lifescience , Ltd. | 2006-02-22 |