FDA PMA
Approved (Reclassification)
🇺🇸 United States
PMA: P920051
·
Supplement: S001
·
Decision Dec 19, 1995
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- STORZ MODULITH (TM) LITHOTRIPTER
- PMA Number
- P920051
- Supplement Number
- S001
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- December 19, 1995
- Date Received
- July 24, 1995
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AMOBILE VERSION OF THE STORZ MODULITH LITHOTRIPTER, MODEL SL20