OCUCOAT SYRINGE PRODUCT
FDA premarket approval P860047/S025 · decided 2012-02-03
Approval details
- PMA number
- P860047
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OCUCOAT SYRINGE PRODUCT
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-11-18
- Decision date
- 2012-02-03
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE ELASTOMERIC TIP CAP MATERIAL (FM27) AND THE ADDITION OF A THREADED PLASTIC RIGID TIP CAP (PRTC) OUTER SHELL.
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