LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C
FDA premarket approval P870018/S014 · decided 1996-06-06
Approval details
- PMA number
- P870018
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1996-03-13
- Decision date
- 1996-06-06
- Days to decision
- 85 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- Statement
- APPROVAL FOR 1)MODIFICATIONS TO A PROGRAMMABLE READ ONLY MEMORY INTEGRATED CIRCUIT; AND 2)MINOR LABELING CHANGES. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C
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