Aveir VR Leadless System 510(k) FDA Approval

Device	Aveir VR Leadless System
Generic Name	Pulse-generator, Single Chamber, Sensor Driven, Implantable
Applicant	Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Date Received10/06/2015 Decision Date03/31/2022 Product Code LWO Advisory Committee Cardiovascular Clinical TrialsNCT01700244 Expedited Review Granted? No
Date Received	2015-10-06
Decision Date	2022-03-31
PMA	P150035
Supplement	S
Product Code	LWO
Advisory Committee	Cardiovascular
Expedited Review	No
Combination Product	Yes
Applicant Address	Abbott Medical 15900 Valley View Court sylmar, CA 91342 PMA NumberP150035 Date Received10/06/2015 Decision Date03/31/2022 Product Code LWO Advisory Committee Cardiovascular Clinical TrialsNCT01700244 Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For The Aveir™ Leadless Pacemaker, Aveir™ Delivery System Catheter, And Aveir™ Link Module. Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling Labeling Part 2 Post-Approval StudyShow Report Schedule And Study Progress Supplements:
Post-Approval Study:	Show Report Schedule and Study Progress

Aveir VR Leadless System