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

• Device: Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M
• Generic Name: Pulse-generator, Single Chamber, Sensor Driven, Implantable
• Applicant: Abbott 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 Received: 2022-04-18
• Decision Date: 2022-05-04
• PMA: P150035
• Supplement: S001
• Product Code: LWO
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Abbott 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 Number	Date	Supplement Type
P150035		Original Filing
S002	2022-09-21	30-day Notice
S001	2022-04-18	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
05415067036384	P150035	000
05415067034472	P150035	000
05415067031914	P150035	000
05415067038487	P150035	003
05415067040725	P150035	003
05415067040701	P150035	003
05415067046475	P150035	007
05415067046468	P150035	007
05415067049971	P150035	007