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: ANGIOLINK VASCULAR CLOSURE SYSTEM
• Generic Name: Device, hemostasis, vascular
• Applicant: Medtronic Vascular; 37a Cherry Hill Dr.; Danvers, MA 01923
• PMA Number: P040022
• Supplement Number: S001
• Date Received: 05/15/2006
• Decision Date: 10/02/2006
• Withdrawal Date: 10/12/2010
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 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  
APPROVAL FOR VARIOUS MANUFACTURING PROCESS CHANGES TO ENSURE CONSISTENCY.