Analyzer, Pacemaker Generator Function

Device Code: 781

Product Code(s): DTC

Device Classification Information

• Device Type ID: 781
• Device Name: Analyzer, Pacemaker Generator Function
• Regulation Description: Pacemaker Generator Function Analyzer.
• 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: 870.3630 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DTC
• 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: 781
• Device: Analyzer, Pacemaker Generator Function
• Product Code: DTC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pacemaker Generator Function Analyzer.
• CFR Regulation Number: 870.3630 [🔎]

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Computer Software Problem	36
Communication Or Transmission Problem	15
Device Displays Incorrect Message	15
Computer Operating System Problem	6
Output Problem	4
Device Sensing Problem	4
Data Problem	4
Device Difficult To Program Or Calibrate	3
Capturing Problem	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2
Pacing Problem	2
Impedance Problem	2
Mechanical Problem	1
Program Or Algorithm Execution Problem	1
Power Problem	1
Device Operational Issue	1
Total Device Problems	99

TPLC Last Update: 2019-04-02 19:41:25