PMA P920034S001
- Device
- TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
- Applicant
- MEDIREX, INC.
- PMA number
- P920034
- Supplement
- S001
- Product code
- LNS
- Decision date
- 1997-03-26
- Generic name
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Approval order statement
- APPROVAL FOR LABELING CHANGES DESCRIBING THE TRANSPORTABILITY OF THE DEVICE
Current openFDA PMA Record
- Device
- TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
- Applicant
- Medirex, Inc.
- PMA number
- P920034
- Supplement
- S001
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-03-26
- Decision code
- APRL
- Date received
- 1997-03-18
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES DESCRIBING THE TRANSPORTABILITY OF THE DEVICE