UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. is an FDA 510(k)-cleared medical device (K811350) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on June 30, 1981. Regulation: 8.