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: ACCULINK, RX
• Generic Name: Stent, carotid
• Applicant: Abbott Vascular; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P040012
• Supplement Number: S045
• Date Received: 05/24/2012
• Decision Date: 06/21/2012
• Product Code: NIM
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.