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 | MODIFIED J-LOOP POSTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | EYEKON MEDICAL, INC. 2451 ENTERPRISE RD. CLEARWATER, FL 33763 |
PMA Number | P880072 |
Supplement Number | S036 |
Date Received | 08/25/1995 |
Decision Date | 02/12/1996 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION |
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