PMA P870018S016
- Device
- LITHOSTAR
- Applicant
- Siemens Corp.
- PMA number
- P870018
- Supplement
- S016
- Product code
- LNS
- Decision date
- 1996-06-21
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR MODIFYING YOUR USER'S MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR
Current openFDA PMA Record#
- Device
- LITHOSTAR
- Applicant
- Siemens Corp.
- PMA number
- P870018
- Supplement
- S016
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-06-21
- Decision code
- APRL
- Date received
- 1996-05-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFYING YOUR USER'S MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR