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 V AND PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
• Generic Name: Coronary drug-eluting stent
• Applicant: Abbott Vascular, Inc.; 26531 Ynez Rd., Bldg. G; P.O. Box 9018; Temecula, CA 92589
• PMA Number: P070015
• Supplement Number: S013
• Date Received: 02/26/2009
• Decision Date: 03/16/2009
• Withdrawal Date: 04/26/2023
• 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  
INCREASE OF THE RELATIVE HUMIDITY SPECIFICATION IN THE CLEAN ROOM.