PMA P840008S068
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S068
- Product code
- LNS
- Decision date
- 1999-02-26
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for the use of two alternative patient labels with the Dornier Compact Delta and Compact S Lithotripters.
Current openFDA PMA Record#
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S068
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-02-26
- Decision code
- APRL
- Date received
- 1999-02-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of two alternative patient labels with the Dornier Compact Delta and Compact S Lithotripters.