BD 1% OVD
FDA premarket approval P960011/S012 · decided 2006-12-19
Approval details
- PMA number
- P960011
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BD 1% OVD
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2006-11-01
- Decision date
- 2006-12-19
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL TO CHANGE THE TRADE NAME FROM BIOLON TO BD1% OVD.
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