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 | LITHOSTAR MULTILINE |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH ISELIN, NJ 08830 |
PMA Number | P870018 |
Supplement Number | S017 |
Date Received | 06/17/1997 |
Decision Date | 08/26/1998 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
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 a new configuration of the Lithostar(R). The device, as modified, will be marketed under the trade name Lithostar(R) Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm. |
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