PMA P840008S056
- Device
- DORNIER COMPACT S
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S056
- Product code
- LNS
- Decision date
- 1996-11-05
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- 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
Current openFDA PMA Record#
- Device
- DORNIER COMPACT S
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S056
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-11-05
- Decision code
- APRL
- Date received
- 1996-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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