PMA P840008S052
- Device
- DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S052
- Product code
- LNS
- Decision date
- 1995-10-05
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR A NEW MODEL LITHOTRIPTER, THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DORNIER LITHOTRIPTER TRANSPORTABLE
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S052
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1995-10-05
- Decision code
- APRL
- Date received
- 1995-08-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW MODEL LITHOTRIPTER, THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DORNIER LITHOTRIPTER TRANSPORTABLE