tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval N17679/S040 · decided 2018-06-29
Approval details
- PMA number
- N17679
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-06-07
- Decision date
- 2018-06-29
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Replacement of the paper system used for managing the preparation and documentation of the solution records at the CooperVision, Inc. Scottsville, NY manufacturing facility with a computer based system.
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