PROVISC VISCOELASTIC MATERIAL
FDA premarket approval P890047/S011 · decided 1998-03-17
Approval details
- PMA number
- P890047
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROVISC VISCOELASTIC MATERIAL
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 1996-12-04
- Decision date
- 1998-03-17
- Days to decision
- 468 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the incorporation of VISCOAT and PROVISC, which make up the DUOVISC product, into a single plastic tray, to be sterilized and processed at Alcon's Puerto Rico; and a change in the sterilization process at Alcon's Puerto Rico facility for the DUOVISC System.
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