|
Device | UV ABSORBING POSTERIOR 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 | P970034 |
Supplement Number | S010 |
Date Received | 12/20/2007 |
Decision Date | 04/17/2008 |
Withdrawal Date
|
08/20/2014 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN LENS POLISH. |