PMA P960030S077

Device: IsoFlex
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S077
Product code: NVN
Decision date: 2022-12-07
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.

Current openFDA PMA Record#

Device: IsoFlex
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S077
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2022-12-07
Decision code: APPR
Date received: 2022-09-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.