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 | UV-ABSORBING 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 | S013 |
Date Received | 10/09/2009 |
Decision Date | 11/13/2009 |
Withdrawal Date
|
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 |
Recalls | CDRH Recalls |
Approval Order Statement ACQUISITION OF ONE PIECE OF EQUIPMENT AND THE ADDITION OF A TEST FACILITY. |
|
|