|
Device | STAAR SURGICAL IMPLANTABLE COLLAMER LENS |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S016 |
Date Received | 07/15/2010 |
Decision Date | 08/26/2010 |
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 CHANGE TO THE ALUMINUM CRIMP CAPS USED AS PART OF THE PACKAGING FOR THE IOLS. |