DURASOFT 3 (PHEMFILCON A) LENSES
FDA premarket approval P830037/S037 · decided 1994-05-27
Approval details
- PMA number
- P830037
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASOFT 3 (PHEMFILCON A) LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1994-04-11
- Decision date
- 1994-05-27
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
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