COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS
FDA premarket approval P810057/S003 · decided 1988-08-11
Approval details
- PMA number
- P810057
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1988-03-30
- Decision date
- 1988-08-11
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
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