IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD is an FDA 510(k)-cleared medical device (K792052) manufactured by Telectronics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 21, 1979. Regulation: 8.