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Device | STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S009 |
Date Received | 07/23/2008 |
Decision Date | 09/10/2008 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING. |