METHAFILCON A AND B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
FDA premarket approval P850079/S068 · decided 2015-10-15
Approval details
- PMA number
- P850079
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METHAFILCON A AND B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2015-09-04
- Decision date
- 2015-10-15
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- CHANGE IN MATERIAL (FINA) FOR THE BLISTER PACKAGING AND NEW SUPPLIER FOR THIS MATERIAL.
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