HYDRELLE
FDA premarket approval P050033/S007 · decided 2009-06-01
Approval details
- PMA number
- P050033
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRELLE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2009-05-15
- Decision date
- 2009-06-01
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A CHANGE IN THE DEVICE NAME FROM ELEVESS TO HYDRELLE.
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510(k) clearances by this applicant
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|---|---|---|
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
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| 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 |