PMA P970019S005
- Device
- LITHO TRON LITHOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S005
- Product code
- LNS
- Decision date
- 1998-11-17
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for use of a new patient table model with the LithoTron(TM) Lithotripsy System, with associated labeling changes.
Current openFDA PMA Record#
- Device
- LITHO TRON LITHOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S005
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-11-17
- Decision code
- APRL
- Date received
- 1998-11-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of a new patient table model with the LithoTron(TM) Lithotripsy System, with associated labeling changes.