• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device leadless pacemaker
Regulation Description Implantable pacemaker pulse generator.
Definition To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Product CodePNJ
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 12 4

Device Problems
Capturing issue 42
High capture threshold 30
No Known Device Problem 22
Positioning Issue 14
Failure to capture 13
Undersensing 7
Use of Device Issue 6
No code available 5
Impedance issue 5
Device sensing issue 4
Device operates differently than expected 3
Unstable capture threshold 3
Decreased sensitivity 3
Failure to pace or properly pace 3
Unable to obtain readings 2
Premature discharge of battery 2
Intermittent capture 2
Battery issue 2
Oversensing 2
Dislodged or dislocated 2
Inappropriate or unexpected reset 1
Communication or transmission issue 1
Protective measure issue 1
Output issue 1
Electrical issue 1
High impedance 1
Failure to interrogate 1
Kinked 1
Leak 1
Incorrect measurement 1
Migration of device or device component 1
Total Device Problems 183

-
-