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 | SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | LENSTEC, INC. 1765 COMMERCE AVE N ST. PETERSBURG, FL 33716 |
PMA Number | P090022 |
Supplement Number | S012 |
Date Received | 04/20/2012 |
Decision Date | 01/29/2013 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00963742
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PRELOADED INJECTOR (PLI) INTRAOCULAR LENS (IOL) DELIVERY SYSTEM. |
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