LITHOSTAR MULTILINE
FDA premarket approval P870018/S019 · decided 1997-12-29
Approval details
- PMA number
- P870018
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LITHOSTAR MULTILINE
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1997-12-11
- Decision date
- 1997-12-29
- Days to decision
- 18 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- Statement
- Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
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