PMA P970019S002
- Device
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S002
- Product code
- LNS
- Decision date
- 1998-07-14
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for non-synchronized shockwave delivery.
Current openFDA PMA Record#
- Device
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Applicant
- Healthtronics Surgical Services, Inc.
- PMA number
- P970019
- Supplement
- S002
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-07-14
- Decision code
- APRL
- Date received
- 1998-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for non-synchronized shockwave delivery.