PMA P030035S209

Device: Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S209
Product code: NKE
Decision date: 2025-05-22
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: an alternate and additional supplier for the sterile barrier Tyvek lids used in Cardiac Rhythm Management (CRM) devices

Current openFDA PMA Record#

Device: Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S209
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-05-22
Decision code: OK30
Date received: 2025-04-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternate and additional supplier for the sterile barrier Tyvek lids used in Cardiac Rhythm Management (CRM) devices