PMA P140033S099

Device: Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI
Applicant: ABBOTT MEDICAL
PMA number: P140033
Supplement: S099
Product code: LWP
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: changing the bioburden action level/action limit requirements

Current openFDA PMA Record#

Device: Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI
Applicant: ABBOTT MEDICAL
PMA number: P140033
Supplement: S099
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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