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 | SILICONE INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910061 |
Supplement Number | S009 |
Date Received | 06/11/2003 |
Decision Date | 08/13/2003 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS. |
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