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 | DORNIER COMPACT S |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P840008 |
Supplement Number | S056 |
Date Received | 07/01/1996 |
Decision Date | 11/05/1996 |
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 DESIGN MODIFICATIONS:1)THE USE OF THE PERFORMA ULTRASOUND IMAGING SYSTEM 2)ADDITION OF X-RAY IMAGING AND 3)MINOR DESIGN CHANGES. THE DEVICE AS MODIFIED WILL E MARKETD UNDER THE TRADE NAME DORNIER COMPACT S LITHOTRIPTER AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES |
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