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 | POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | AAREN SCIENTIFIC 4290 EAST BRICKELL ST, BLDG A ONTARIO, CA 91761 |
PMA Number | P970034 |
Supplement Number | S005 |
Date Received | 02/14/2000 |
Decision Date | 03/27/2000 |
Withdrawal Date
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08/20/2014 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis. |
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