STAARVISC II & SHELLGEL SODIUM HYAURONATE
FDA premarket approval P000046/S015 · decided 2012-03-27
Approval details
- PMA number
- P000046
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAARVISC II & SHELLGEL SODIUM HYAURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2009-05-27
- Decision date
- 2012-03-27
- Days to decision
- 1035 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE FROM THE PREVIOUS FACILITY IN WEST CUMMINGS PARK, WOBURN, MASSACHUSETTS TO THE NEW FACILITY LOCATED IN BEDFORD, MASSACHUSETTS. IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL TO CHANGE THE TERMINAL STERILIZATION METHOD OF THE PRODUCT FROM E-BEAM CONTROLLED DEPTH STERILIZATION TO VAPORIZED HYDROGEN PEROXIDE (VHP) GAS STERILIZATION.
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 |