FREQUENCY XCEL TORIC XR
FDA premarket approval P850079/S069 · decided 2015-11-12
Approval details
- PMA number
- P850079
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREQUENCY XCEL TORIC XR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2015-10-19
- Decision date
- 2015-11-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- THE TRANSFER OF FREQUENCY XCEL TORIC XR (METHAFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES MANUFACTURING PROCESS FROM DRY LINE S TO DRY LINE 1.
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