FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
FDA premarket approval P870024/S045 · decided 2005-01-07
Approval details
- PMA number
- P870024
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
- Generic name
- Lens, contact (orthokeratology)
- Applicant
- CooperVision, Inc.
- Date received
- 2004-12-15
- Decision date
- 2005-01-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MUW
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
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