Aveir VR Leadless System

FDA Premarket Approval P150035

Pre-market Approval Supplement Details

DeviceAveir VR Leadless System
Generic NamePulse-generator, Single Chamber, Sensor Driven, Implantable
ApplicantAbbott 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 Received2015-10-06
Decision Date2022-03-31
PMAP150035
SupplementS
Product CodeLWO 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductYes
Applicant AddressAbbott 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

Supplemental Filings

Supplement NumberDateSupplement Type
P150035Original Filing
S002 2022-09-21 30-day Notice
S001 2022-04-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05415067036384 P150035 000
05415067034472 P150035 000
05415067031914 P150035 000
05415067038487 P150035 003
05415067040725 P150035 003
05415067040701 P150035 003

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