BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P780007/S046 · decided 2011-10-21
Approval details
- PMA number
- P780007
- Supplement
- S046
- 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
- 2011-09-22
- Decision date
- 2011-10-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- ADDITION OF STERILIZATION CYCLE RUNS FOR SINGLE BLISTERS, CVI BLISTERS AND SIX PACK BLISTERS TO STERILIZER FEDEGARI.
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