PMA P840008S064
- Device
- DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S064
- Product code
- LNS
- Decision date
- 1998-06-05
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- 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.
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S064
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-06-05
- Decision code
- APRL
- Date received
- 1998-05-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.