Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M

FDA Premarket Approval P150035 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceAveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M
Generic NamePulse-generator, Single Chamber, Sensor Driven, Implantable
ApplicantAbbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-18
Decision Date2022-05-04
PMAP150035
SupplementS001
Product CodeLWO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressAbbott Medical
15900 Valley View Court
sylmar, CA 91342 PMA NumberP150035 Supplement NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
updating The Docking Button Cleaning Line From Manual To An Automated Cleaning System

Supplemental Filings

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

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