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: VALITUDE CRT-P
• Generic Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Applicant: GUIDANT CORP.; 4100 HAMLINE AVENUE NORTH; ST. PAUL, MN 55112-5798
• PMA Number: P030005
• Supplement Number: S128
• Date Received: 07/17/2015
• Decision Date: 08/08/2015
• Product Code: NKE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.