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 | STORZ MODULITH (TM) LITHOTRIPTER |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P920051 |
Supplement Number | S001 |
Date Received | 07/24/1995 |
Decision Date | 12/19/1995 |
Reclassified Date
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09/08/2000 |
Advisory Committee |
Gastroenterology/Urology |
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 AMOBILE VERSION OF THE STORZ MODULITH LITHOTRIPTER, MODEL SL20 |
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