METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES
FDA premarket approval P850079/S072 · decided 2017-02-13
Approval details
- PMA number
- P850079
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-01-19
- Decision date
- 2017-02-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Use of Getinge autoclave A as back up equipment for the sterilization of lathing produced products (3 pack Blisters and Vials) in the event of breakdown or service of lathing autoclaves K and M at the CooperVision, Inc. Hamble UK manufacturing facility.
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