STORZ MODULITH (TM) LITHOTRIPTER
FDA premarket approval P920051/S002 · decided 1995-12-11
Approval details
- PMA number
- P920051
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STORZ MODULITH (TM) LITHOTRIPTER
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1995-09-18
- Decision date
- 1995-12-11
- Days to decision
- 84 days
- Decision code
- APRL
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1)INCLUSION OF AN UPGRADED VIDEO MIXER; 2) MODIFICATION OF THE WATER CIRCUIT TO INCLUDE PRESSURE FEEDBACK; 3) REPLACEMENT OF THE NYLON/ALUMINUM PATIENT TABLE WITH A CARBON FIBER MODEL; 4) ADDITION OF THE FVP-30 X-RAY IMAGE PROCESSING FEATURE (WHICH ALSO INCLUDED REVISIONS OT THE X-RAY OPERATOR'S AND SERVICE MANUALS)
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