PMA P840008S053
- Device
- DORNIER LITHOTRIPTER MOBILE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S053
- Product code
- LNS
- Decision date
- 1996-04-11
- 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 MOBILE
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER MOBILE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S053
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-04-11
- Decision code
- APRL
- Date received
- 1995-12-04
- 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 MOBILE