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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 HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP870024
Supplement NumberS055
Date Received07/23/2020
Decision Date08/18/2020
Product Code MWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Qualification of a second supplier of a raw material monomer used in the manufacture of Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), and Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable (RGP) Contact Lenses.
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