MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 is an FDA 510(k)-cleared medical device (K900984) 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 May 2, 1990. Regulation: 8.