PMA P030035S210

Device: Allure™ PM3120; Allure Quadra™ RF PM3242; Allure Quadra™ PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542;
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S210
Product code: NKE
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: changing the bioburden action level/action limit requirements

Current openFDA PMA Record#

Device: Allure™ PM3120; Allure Quadra™ RF PM3242; Allure Quadra™ PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542;
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S210
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-06-18
Decision code: OK30
Date received: 2025-05-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changing the bioburden action level/action limit requirements