510(k) K854560

IMPLANTABLE PROGRAMMABLE PULSE GENERATOR by Telectronics, Inc. — Product Code DXY

K854560 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "IMPLANTABLE PROGRAMMABLE PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on January 16, 1986. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Telectronics, Inc. has at least 10 other 510(k) clearances on record.