510(k) K883087

PROLOG MP 658M PULSE GENERATOR by Pacesetter Systems — Product Code DXY

K883087 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "PROLOG MP 658M PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on September 14, 1988. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Pacesetter Systems has at least 10 other 510(k) clearances on record.