PMA P840008S066
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S066
- Product code
- LNS
- Decision date
- 1998-08-21
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for modifications to the X-ray module, changes to the device labeling, and approval of the mobile and transportable versions of the Compact Delta.
Current openFDA PMA Record#
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S066
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-08-21
- Decision code
- APRL
- Date received
- 1998-07-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the X-ray module, changes to the device labeling, and approval of the mobile and transportable versions of the Compact Delta.