PMA P840008S054
- Device
- DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S054
- Product code
- LNS
- Decision date
- 1996-10-08
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR (I) A PATIENT AUTOMATIC POSITIONING FEATURE, (II) PATIENT DATA MANAGMENT SOFTWARE, (III) THE PERFORMA ULTRASOUND SYSTE, AND (IV) MINOR DEVICE MODIFICATIONS TO BOTH THE DORNIER LITHOTRIPTER AND THE DORNIER LITHOTRIPTER TRANSPORTABLE
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S054
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-10-08
- Decision code
- APRL
- Date received
- 1996-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR (I) A PATIENT AUTOMATIC POSITIONING FEATURE, (II) PATIENT DATA MANAGMENT SOFTWARE, (III) THE PERFORMA ULTRASOUND SYSTE, AND (IV) MINOR DEVICE MODIFICATIONS TO BOTH THE DORNIER LITHOTRIPTER AND THE DORNIER LITHOTRIPTER TRANSPORTABLE