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 | LENSTEC SOFTEC HD 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 | S014 |
Date Received | 08/27/2012 |
Decision Date | 09/20/2012 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCLUSION OF TWO ADDITIONAL STEAM STERILIZER UNITS FOR THE STERILIZATION OF THE FIRM'S SOFTEC SERIES OF IOLS. |
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