PMA P970019S001
- Device
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S001
- Product code
- LNS
- Decision date
- 1997-11-10
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval to offer the HealthTronics LithoTron(TM) Lithotripsy System in both a mobile and transportable version.
Current openFDA PMA Record#
- Device
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S001
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-11-10
- Decision code
- APRL
- Date received
- 1997-11-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to offer the HealthTronics LithoTron(TM) Lithotripsy System in both a mobile and transportable version.