STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
FDA premarket approval P920051/S007 · decided 1997-10-31
Approval details
- PMA number
- P920051
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1997-10-02
- Decision date
- 1997-10-31
- Days to decision
- 29 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- 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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