DURASOFT R3 (PHEMFILCON A) LENSES
FDA premarket approval P830037/S034 · decided 1994-01-31
Approval details
- PMA number
- P830037
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASOFT R3 (PHEMFILCON A) LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1993-02-26
- Decision date
- 1994-01-31
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
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