PMA P870024S045
- Device
- FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
- Applicant
- CooperVision, Inc.
- PMA number
- P870024
- Supplement
- S045
- Product code
- MUW
- Decision date
- 2005-01-07
- Classification
- Lens, Contact (orthokeratology)
- Generic name
- Lens, contact (orthokeratology)
- Approval order statement
- MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
Current openFDA PMA Record#
- Device
- FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
- Applicant
- CooperVision, Inc.
- PMA number
- P870024
- Supplement
- S045
- Product code
- MUW
- Generic name
- Lens, contact (orthokeratology)
- Decision date
- 2005-01-07
- Decision code
- OK30
- Date received
- 2004-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.