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. |
|
Device | MODULARIS LITHO |
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 | S021 |
Date Received | 05/01/1998 |
Decision Date | 09/21/1998 |
Reclassified Date
|
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 compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones. |
|
|