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 HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P870024 |
Supplement Number | S055 |
Date Received | 07/23/2020 |
Decision Date | 08/18/2020 |
Product Code |
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 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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