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. |
|
Device | 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 | S015 |
Date Received | 02/22/2008 |
Decision Date | 03/21/2008 |
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 |
Approval Order Statement IMPLEMENTATION OF NEW SEMI-AUTOMATED PRODUCTION EQUIPMENT FOR THE BLOCKING PROCESS. |
|
|