PMA P840008S061
- Device
- DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S061
- Product code
- LNS
- Decision date
- 1997-11-03
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S061
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-11-03
- Decision code
- APRL
- Date received
- 1997-10-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.