FDA Product Code DTE: Pulse-generator, Pacemaker, External
Leading manufacturers include Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. and Solo Pace, Inc..
FDA 510(k) Cleared Pulse-generator, Pacemaker, External Devices (Product Code DTE)
About Product Code DTE - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code DTE since 1978, with 65 receiving FDA clearance (average review time: 111 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under DTE have taken an average of 204 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.
DTE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →