Tester, Pacemaker Electrode Function

Device Code: 779

Product Code(s): DTA

Device Classification Information

• Device Type ID: 779
• Device Name: Tester, Pacemaker Electrode Function
• Regulation Description: Pacemaker Electrode Function Tester.
• 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: 870.3720 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DTA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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: 779
• Device: Tester, Pacemaker Electrode Function
• Product Code: DTA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pacemaker Electrode Function Tester.
• CFR Regulation Number: 870.3720 [🔎]

Premarket Reviews
Manufacturer	Decision
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:41:11