BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES
FDA premarket approval P780007/S042 · decided 1999-12-14
Approval details
- PMA number
- P780007
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-09-17
- Decision date
- 1999-12-14
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico.
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