PMA approvals

AVEIR VR Real-World Evidence Study

ABBOTT MEDICAL · Leadless pacemaker · Cardiovascular

P150035 S042SupplementApproved
Open FDA's page for this record
PMA number
P150035
Supplement number
S042
Applicant
ABBOTT MEDICAL
Street 1
15900 Valley View Ct.
City
Sylmar
State
CA
Zip
91342
Generic name
Leadless pacemaker
Trade name
AVEIR VR Real-World Evidence Study
Product code
PNJ
Advisory committee
CV
Advisory committee description
Cardiovascular
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Expedited review flag
N
Date received
2026-09-25
Decision date
2026-10-21
Decision code
APPR
Ao statement

approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150035/S041.

Harmonized identifiers (openFDA)
Device name
Leadless Pacemaker
Medical specialty description
Cardiovascular
Regulation number
870.3610
Device class
3
Registration number
3003120897, 3010849408, 2133641, 9614453, 3009380063, 3006705815, 2017865, 3002807314, 9612164, 2182208, 3013288201
FEI number
3003120897, 3010849408, 3000203466, 3002806434, 3002807576, 3009380063, 3006705815, 2017865, 3002807314, 2182208, 3013288201
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.