STAARVISC II, SHELLGEL AND COEASE
FDA premarket approval P000046/S008 · decided 2003-05-22
Approval details
- PMA number
- P000046
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II, SHELLGEL AND COEASE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2003-04-25
- Decision date
- 2003-05-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- MANUFACTURING CHANGE FOR AN ADDITIONAL PROCESS CONTROL TREATMENT FOR STAARVISC II, SHELLGEL AND COEASE.
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