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Device | STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STARR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P990013 |
Supplement Number | S016 |
Date Received | 03/20/2008 |
Decision Date | 04/16/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement IMPLEMENTATION OF A MODIFIED MANUFACTURING PROCESS FOR THE COLLAMER LENSES MANUFACTURED AT THE SWITZERLAND FACILITY. |