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 | Visian Implantable Collamer Lens |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S039 |
Date Received | 06/27/2019 |
Decision Date | 07/26/2019 |
Product Code |
MTA |
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 the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices. |
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