PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
FDA premarket approval P890047/S027 · decided 2008-12-23
Approval details
- PMA number
- P890047
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Trade name
- PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2008-11-24
- Decision date
- 2008-12-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.
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