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 | DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) |
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 | S064 |
Date Received | 05/26/1998 |
Decision Date | 06/05/1998 |
Reclassified Date
|
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 to the therapy head positioning, modifications of the control panel, addition of a servicing modem, changes to the air flow within the device, material changes to the patient table, ECG monitor model replacement, change of the available X-ray features, software modifications, labeling changes, and integration of the water circulation device with its control computer. The device, as modified, will be marketed under the trade name Dorneir Lithotripter S and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones. |
|
|