METHAFILCON LENSES: FREQUENCY 55 TORIC, FREQUENCY XED TORIC XR, FREQUENCY 55 TONIC XR. METHAFILCON LENSES: HYDROSOFT XWP
FDA premarket approval P850079/S065 · decided 2013-09-13
Approval details
- PMA number
- P850079
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METHAFILCON LENSES: FREQUENCY 55 TORIC, FREQUENCY XED TORIC XR, FREQUENCY 55 TONIC XR. METHAFILCON LENSES: HYDROSOFT XWP
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2013-08-19
- Decision date
- 2013-09-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- CHANGE TO THE STERILIZATION CYCLE.
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