EVOLENCE COLLAGEN FILLER
FDA premarket approval P070013/S002 · decided 2008-09-15
Approval details
- PMA number
- P070013
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- EVOLENCE COLLAGEN FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Colbar Lifescience , Ltd.
- Date received
- 2008-07-09
- Decision date
- 2008-09-15
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Herzliya
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OSSIX -PLUS (K053260) | Colbar Lifescience , Ltd. | 2006-02-22 |