DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
FDA premarket approval P840008/S058 · decided 1997-05-05
Approval details
- PMA number
- P840008
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1996-12-09
- Decision date
- 1997-05-05
- Days to decision
- 147 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR A NON-ECG SHOCK WAVE TRIGGER MODE FOR THE DORNIER COMPACT S AND THE MOVE AND SHOOT FEATURE FOR THE DORNIER LITHOTRIPTER (STATIONARY AND TRANSPORTABLE).
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