AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear
FDA premarket approval P010019/S061 · decided 2017-11-13
Approval details
- PMA number
- P010019
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2017-10-17
- Decision date
- 2017-11-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Transfer of a raw material pelletization process from in-house to an external supplier and establishing a 3-year shelf life for the raw material based on a stability study completed, thereby removing the periodic material retesting requirement for stability confirmation.
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