PMA P950043S001
- Device
- ECONOLITH(TM) LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S001
- Product code
- LNS
- Decision date
- 1997-06-30
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR A TRANSPORTABLE VERSION OF THE ECONOLITH(TM) LITHOTRIPTER.
Current openFDA PMA Record#
- Device
- ECONOLITH(TM) LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S001
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-06-30
- Decision code
- APRL
- Date received
- 1997-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A TRANSPORTABLE VERSION OF THE ECONOLITH(TM) LITHOTRIPTER.