FDA-Device2013-04-10Class II
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Medtronic Neuromodulation
Hazard
Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equi
Sold states
Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Affected count
848 (696 US, 152 OUS)
Manufactured in
7000 Central Ave NE, N/A, Minneapolis, MN, United States
Products
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1031-2013Don't want to check this manually?
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