Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GORE HELEX SEPTAL OCCLUDER
• Classification Name: transcatheter septal occluder
• Generic Name: septal occluder
• Applicant: W.L. GORE & ASSOCIATES,INC
• PMA Number: P050006
• Supplement Number: S018
• Date Received: 08/17/2010
• Decision Date: 09/15/2010
• Product Code: MLV [ Registered Establishments with MLV ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Changes to the sterilization cycle process.