PMA P870015S030
- Device
- MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S030
- Product code
- LNS
- Decision date
- 1998-09-16
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Current openFDA PMA Record#
- Device
- MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S030
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-09-16
- Decision code
- APRL
- Date received
- 1998-07-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.