PMA P920034S002
- Device
- TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
- Applicant
- Medirex, Inc.
- PMA number
- P920034
- Supplement
- S002
- Product code
- LNS
- Decision date
- 1998-03-05
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for non-electrocardiographic (ECG) gating in patients with renal and upper tract calculi.
Current openFDA PMA Record
- Device
- TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
- Applicant
- Medirex, Inc.
- PMA number
- P920034
- Supplement
- S002
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-03-05
- Decision code
- APRL
- Date received
- 1998-01-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for non-electrocardiographic (ECG) gating in patients with renal and upper tract calculi.