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: SELECTSECURE
• Generic Name: Permanent defibrillator electrodes
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P030036
• Supplement Number: S041
• Date Received: 02/29/2012
• Decision Date: 03/23/2012
• Product Code: NVY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.