PMA P950043S002
- Device
- ECONOLITH(TM) LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S002
- Product code
- LNS
- Decision date
- 1998-05-05
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for non-synchronized ESWL, addition of a ECG simulator/adapter, and appropriate labeling revisions.
Current openFDA PMA Record#
- Device
- ECONOLITH(TM) LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S002
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-05-05
- Decision code
- APRL
- Date received
- 1998-04-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for non-synchronized ESWL, addition of a ECG simulator/adapter, and appropriate labeling revisions.