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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicePARAGON CRT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP050031
Supplement NumberS001
Date Received10/25/2010
Decision Date07/28/2014
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Clinical TrialsNCT01272271
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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