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: ENERGEN CRT-D IS4
• Classification Name: implantable pulse generator, pacemaker (non-crt)
• Generic Name: cardiac resynchronization therapy-defibrillator
• Applicant: BOSTON SCIENTIFIC CORPORATION
• PMA Number: P010012
• Supplement Number: S320
• Date Received: 01/17/2013
• Decision Date: 02/08/2013
• Product Code: LWP [ Registered Establishments with LWP ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of additional spotweld equipment.