BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P780007/S048 · decided 2012-02-09
Approval details
- PMA number
- P780007
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-01-12
- Decision date
- 2012-02-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- ADDITION OF A NEW MICROBIAL AIR SAMPLER AND DESCRIPTION FOR BIOBURDEN MONITORING OF THE CLEAN ROOM.
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