PMA P840008S041
- Device
- MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S041
- Product code
- LNS
- Decision date
- 1992-08-06
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
Current openFDA PMA Record#
- Device
- MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S041
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1992-08-06
- Decision code
- APRL
- Date received
- 1992-06-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename