ELEVESS
FDA premarket approval P050033/S005 · decided 2007-10-03
Approval details
- PMA number
- P050033
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ELEVESS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2007-09-19
- Decision date
- 2007-10-03
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR THE CHANGE IN PRODUCT TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELEVESS AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
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510(k) clearances by this applicant
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|---|---|---|
| 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 |