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: REGENCY
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Generic Name: implantable cardiac pacemaker pulse generator
• Applicant: ST. JUDE MEDICAL
• PMA Number: P880006
• Supplement Number: S083
• Date Received: 09/13/2012
• Decision Date: 10/10/2012
• Product Code: NIK [ Registered Establishments with NIK ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Changes to the bioburden action level and bioburden action limit.