Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES |
Generic Name | Lens, contact (orthokeratology) |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P870024 |
Supplement Number | S044 |
Date Received | 08/31/2004 |
Decision Date | 09/24/2004 |
Product Codes |
MUW MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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