DUOVISC VISCOELASTIC SYSTEM
FDA premarket approval P890047/S009 · decided 1996-03-26
Approval details
- PMA number
- P890047
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUOVISC VISCOELASTIC SYSTEM
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 1995-09-22
- Decision date
- 1996-03-26
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR MANUFACTURE OF DUOVISC AT ALCON-COUVREUR, PUURS, BELGIUM AND A SINGLE BLISTER PACKAGE WHICH WILL CONTAIN BOTH PROVISC AND VISCOAT WITH THEIR DELIVERY CANNULAS (24 MONTHS EXPIRATION)
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