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 | CyPass Micro-Stent |
Generic Name | Intraocular pressure lowering implant |
Applicant | Alcon Research, Ltd 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P150037 |
Supplement Number | S009 |
Date Received | 05/04/2018 |
Decision Date | 05/30/2018 |
Product Code |
OGO |
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 Addition of an alternate additional vendor for the stent cleaning step of the CyPass Micro-Stent manufacturing process. |
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