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: COGNIS CRT MODELS N118, N19
• Classification Name: implantable pulse generator, pacemaker (non-crt)
• Applicant: BOSTON SCIENTIFIC-CRM
• PMA Number: P960040
• Supplement Number: S245
• Date Received: 08/19/2011
• Decision Date: 09/15/2011
• Product Code: LWP [ Registered Establishments with LWP ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate suppliers for ceramic capacitors.