PMA P150035S030

Device: Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S030
Product code: PNJ
Decision date: 2025-09-17
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: to add Midwest Sterilization Corporation as an alternate Ethylene Oxide (EO) sterilization site for the Aveir VR and Aveir DR Delivery Catheters

Current openFDA PMA Record#

Device: Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S030
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2025-09-17
Decision code: APPR
Date received: 2025-07-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add Midwest Sterilization Corporation as an alternate Ethylene Oxide (EO) sterilization site for the Aveir VR and Aveir DR Delivery Catheters