PMA P970062
- Device
- GENESTONE 190 LITHOTRIPTER
- Applicant
- Bmt, Inc.
- PMA number
- P970062
- Product code
- LNS
- Decision date
- 1998-06-24
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for the Genestone 190 Lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.
Current openFDA PMA Record#
- Device
- GENESTONE 190 LITHOTRIPTER
- Applicant
- Bmt, Inc.
- PMA number
- P970062
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-06-24
- Decision code
- APRL
- Date received
- 1997-12-23
- Approval order statement
- Approval for the Genestone 190 Lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.