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 | ANTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | AAREN SCIENTIFIC 4290 EAST BRICKELL ST, BLDG A ONTARIO, CA 91761 |
PMA Number | P010027 |
Supplement Number | S004 |
Date Received | 02/02/2012 |
Decision Date | 03/02/2012 |
Withdrawal Date
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08/20/2014 |
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 ALTERNATE VENDOR TO PERFORM LIMULUS AMEBOCYTE LYSATE (LAL) TESTING. |
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