PACEMAKER PATIENT ADAPTOR MODULE (PPAM)

PACEMAKER PATIENT ADAPTOR MODULE (PPAM) is an FDA 510(k)-cleared medical device (K900213) manufactured by Bomed Medical Mfg., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 1990. Regulation: 8.