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: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE
• Generic Name: Coronary drug-eluting stent
• Applicant: Abbott Vascular; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P110019
• Supplement Number: S072
• Date Received: 09/25/2014
• Decision Date: 10/22/2014
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE TO THE TIMING OF SAMPLING FOR PARTICULATE TESTING FOR PRODUCT RELEASE TESTING.