PMA P920051S002

Device: STORZ MODULITH (TM) LITHOTRIPTER
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S002
Decision date: 1995-12-11
Approval order 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)

Current openFDA PMA Record#

Device: STORZ MODULITH (TM) LITHOTRIPTER
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S002
Decision date: 1995-12-11
Decision code: APRL
Date received: 1995-09-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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)