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 | UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB SURGICAL, INC. 1400 N. GOODMAN ST. ROCHESTER, NY 14609 |
PMA Number | P850059 |
Supplement Number | S023 |
Date Received | 09/21/1999 |
Decision Date | 05/08/2001 |
Withdrawal Date
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11/26/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY. |
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