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 | PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P870024 |
Supplement Number | S049 |
Date Received | 10/25/2010 |
Decision Date | 07/28/2014 |
Product Codes |
MWL NUU |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01272271
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS). |
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