SHELLGEL(TM) SODIUM HYALURONATE
FDA premarket approval P000046/S001 · decided 2001-06-11
Approval details
- PMA number
- P000046
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SHELLGEL(TM) SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2001-05-10
- Decision date
- 2001-06-11
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.
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 |
|---|---|---|
| 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 |