PROVIS OPHTHALMIC VISCOSURGICAL DEVICE
FDA premarket approval P890047/S034 · decided 2011-05-18
Approval details
- PMA number
- P890047
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROVIS OPHTHALMIC VISCOSURGICAL DEVICE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2011-04-19
- Decision date
- 2011-05-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.
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