PMA P000039S076

Device: Amplatzer Septal Occluder and Amplatzer Cribriform Occluder
Applicant: ABBOTT MEDICAL
PMA number: P000039
Supplement: S076
Product code: MLV
Decision date: 2022-01-13
Generic name: Transcatheter septal occluder
Approval order statement: Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.

Current openFDA PMA Record#

Device: Amplatzer Septal Occluder and Amplatzer Cribriform Occluder
Applicant: ABBOTT MEDICAL
PMA number: P000039
Supplement: S076
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2022-01-13
Decision code: APPR
Date received: 2021-11-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.