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 DELTA |
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 | S065 |
Date Received | 06/25/1998 |
Decision Date | 07/07/1998 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelivc stones. |
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