Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: CONTAK RENEWAL TR CRT-P DEVICES
• Classification Name: pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
• Generic Name: cardiac resynchronization therapy pacemaker (crt-p)
• Applicant: BOSTON SCIENTIFIC-CRM
• PMA Number: P030005
• Supplement Number: S083
• Date Received: 04/27/2012
• Decision Date: 05/18/2012
• Product Code: NKE [ Registered Establishments with NKE ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to an existing manufacturing process.