Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: GORE HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095
• Generic Name: Transcatheter septal occluder
• Applicant: W. L. Gore & Associates, Inc.; 32360 N. N. Valley Pkwy.; Phonix, AZ 85085
• PMA Number: P050006
• Supplement Number: S031
• Date Received: 09/05/2012
• Decision Date: 09/27/2012
• Product Code: MLV
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
USE OF ALTERNATE CUTTING EQUIPMENT.