B&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS
FDA premarket approval P830050/S001 · decided 1987-05-08
Approval details
- PMA number
- P830050
- Supplement
- S001
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- B&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS
- Generic name
- Lens, contact (polymethylmethacrylate)
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1987-02-02
- Decision date
- 1987-05-08
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- HPX
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Minnetonka, MN
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