SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
FDA premarket approval P850077/S020 · decided 1995-05-05
Approval details
- PMA number
- P850077
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1994-09-27
- Decision date
- 1995-05-05
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
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