BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
FDA premarket approval P780007/S045 · decided 2011-05-13
Approval details
- PMA number
- P780007
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2011-02-24
- Decision date
- 2011-05-13
- Days to decision
- 78 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- UTILIZE THE DYE PENETRATION TEST METHOD FOR TESTING PACKAGE INTEGRITY.
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