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 | STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S026 |
Date Received | 01/13/2014 |
Decision Date | 02/10/2014 |
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 NEW MANUFACTURING FILTER. |
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