PMA P000049

Device: STARFLEX SEPTAL OCCLUSION SYSTEM
Applicant: Nmt Medical, Inc.
Product code: MLV
Decision date: 2009-03-05
Generic name: Transcatheter septal occluder
Approval order statement: APPROVAL FOR THE ADDITION OF THE STARFLEX VSD OCCLUDER IN THREE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARFLEX SEPTAL OCCLUDER AND IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF A SIGNIFICANT SIZE TO WARRANT CLOSURE, BUT THAT BASED ON LOCATION, CANNOT BE CLOSED WITH STANDARD TRANSATRIAL OR TRANSARTERIAL APPROACHES.

Current openFDA PMA Record

Device: STARFLEX SEPTAL OCCLUSION SYSTEM
Applicant: Nmt Medical, Inc.
PMA number: P000049
Supplement: S016
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2009-03-05
Decision code: APPR
Date received: 2006-03-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE STARFLEX VSD OCCLUDER IN THREE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARFLEX SEPTAL OCCLUDER AND IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF A SIGNIFICANT SIZE TO WARRANT CLOSURE, BUT THAT BASED ON LOCATION, CANNOT BE CLOSED WITH STANDARD TRANSATRIAL OR TRANSARTERIAL APPROACHES.