Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

Device Code: 843

Product Code(s): JOQ

Device Classification Information

• Device Type ID: 843
• Device Name: Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
• Regulation Description: External Programmable Pacemaker Pulse Generator.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.1750 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JOQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-132 ISO 27185 First Edition 2012-02-15
  Cardiac Rhythm Management Devices - Symbols To Be Used With Cardiac Rhythm Management Device Labels, And Information To Be Supplied - General Requirements

Total Product Life Cycle

• Device Type ID: 843
• Device: Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
• Product Code: JOQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: External Programmable Pacemaker Pulse Generator.
• CFR Regulation Number: 870.1750 [🔎]

Premarket Reviews
Manufacturer	Decision
FISCHER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Communication Or Transmission Problem	6
Device Operates Differently Than Expected	1
Pacing Inadequately	1
Low Impedance	1
Adverse Event Without Identified Device Or Use Problem	1
Smoking	1
Failure To Power Up	1
Output Problem	1
Total Device Problems	13

TPLC Last Update: 2019-04-02 19:43:03