DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE
FDA premarket approval P840008/S069 · decided 1999-09-02
Approval details
- PMA number
- P840008
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1999-08-20
- Decision date
- 1999-09-02
- Days to decision
- 13 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.
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