PMA P900060S041

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S041
Product code: LWQ
Decision date: 2011-12-21
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL TO EXTEND THE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY FROM 1.5 TESLA TO 3.0 TESLA AND TO INCORPORATE OTHER LABELING REVISIONS FOR THE PURPOSE OF UNIFYING AND REBRANDING THE US MARKET LABELS WITH OTHER, NON-US MARKET LABELS.

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S041
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2011-12-21
Decision code: APPR
Date received: 2011-02-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXTEND THE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY FROM 1.5 TESLA TO 3.0 TESLA AND TO INCORPORATE OTHER LABELING REVISIONS FOR THE PURPOSE OF UNIFYING AND REBRANDING THE US MARKET LABELS WITH OTHER, NON-US MARKET LABELS.