BVI 1% OVD
FDA premarket approval P960011/S026 · decided 2014-08-12
Approval details
- PMA number
- P960011
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BVI 1% OVD
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2014-07-15
- Decision date
- 2014-08-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- ADDITION OF A NEW AUTOMATED THERMOFORMING MACHINE ANDPACKAGING PROCESS.
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