|
Device | SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | LENSTEC, INC. 1765 COMMERCE AVE N ST. PETERSBURG, FL 33716 |
PMA Number | P090022 |
Supplement Number | S009 |
Date Received | 08/31/2011 |
Decision Date | 11/16/2011 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00963742
|
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE WAY IN WHICH A TEST REAGENT IS INCUBATED. |