VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE
FDA premarket approval P890047/S040 · decided 2013-04-04
Approval details
- PMA number
- P890047
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2013-03-08
- Decision date
- 2013-04-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- USE ONE GENERIC ¿WORST CASE¿ TEST BIOLOGICAL INDICATOR (BI) BLISTER AS AN ALTERNATIVE TO THE PRODUCT-SPECIFIC BI BLISTER FOR USE DURING ETO STERILIZATION.
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