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 | ISERT PY-60AD |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVENUE CHINO HILLS, CA 91709 |
PMA Number | P080004 |
Supplement Number | S007 |
Date Received | 04/27/2011 |
Decision Date | 06/15/2011 |
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 FOR PACKAGING CHANGES TO THE MODEL PY-60AD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT MODEL PY-60ADC AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED. |
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