PMA P040021S020

Device: EPIC VALVE
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S020
Product code: LWQ
Decision date: 2012-11-01
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.

Current openFDA PMA Record#

Device: EPIC VALVE
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S020
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2012-11-01
Decision code: APPR
Date received: 2011-08-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.