PMA P840008S060
- Device
- DORNIER COMPACT S TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S060
- Product code
- LNS
- Decision date
- 1996-12-20
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL OF A TRANSPORTABLE VERSION OF THE COMPACT S LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DORNIER COMPACT S TRANSPORTABLE 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 COMPACT S TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S060
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-12-20
- Decision code
- APRL
- Date received
- 1996-12-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF A TRANSPORTABLE VERSION OF THE COMPACT S LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DORNIER COMPACT S TRANSPORTABLE AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES.