HYDRASOFT (METHAFILCON A) CONTACT LENS
FDA premarket approval P850079/S013 · decided 1989-09-06
Approval details
- PMA number
- P850079
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRASOFT (METHAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1989-02-06
- Decision date
- 1989-09-06
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
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