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 SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES WITH PLATE HAPTICS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P910058 |
Supplement Number | S010 |
Date Received | 09/09/1999 |
Decision Date | 05/09/2001 |
Withdrawal Date
|
09/17/2010 |
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 MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA. |
|
|