PMA P840008S045
- Device
- MODEL MFL 5000 LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S045
- Product code
- LNS
- Decision date
- 1995-04-12
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
Current openFDA PMA Record#
- Device
- MODEL MFL 5000 LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S045
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1995-04-12
- Decision code
- APRL
- Date received
- 1993-03-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename