COSMETIC TISSUE AUGMENTATION PRODUCT
FDA premarket approval P050033/S001 · decided 2007-07-16
Approval details
- PMA number
- P050033
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSMETIC TISSUE AUGMENTATION PRODUCT
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2007-01-03
- Decision date
- 2007-07-16
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL PRODUCT FROM 12 MM TO 50 MM SODIUM PHOSPHATE; 2) THE INTRODUCTION OF AN ANTIOXIDANT, I.E., 0.1% SODIUM METABISULFITE, INTO THE FINAL PRODUCT; AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| Tactoset® Injectable Bone Substitute (K231968) | Anika Therapeutics, Inc. | 2023-12-20 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
| Integrity™ Bone Staple Fixation System (K223860) | Anika Therapeutics, Inc. | 2023-05-22 |
| Anika Tissue Tack Fixation System (K222487) | Anika Therapeutics, Inc. | 2023-05-08 |
| Tactoset (K223915) | Anika Therapeutics, Inc. | 2023-03-29 |
| Tactoset Injectable Bone Substitute (K212083) | Anika Therapeutics, Inc. | 2021-08-31 |
| SCS 17-01 (K190956) | Anika Therapeutics, Inc. | 2020-01-30 |