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: PARADYM VR & DR
• Classification Name: defibrillator, implantable, dual-chamber
• Generic Name: implantable cardioverter-defibrillator with active housing
• Applicant: ELA MEDICAL, INC.
• PMA Number: P980049
• Supplement Number: S067
• Date Received: 11/14/2011
• Decision Date: 12/12/2011
• Product Code: MRM [ Registered Establishments with MRM ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate equipment for the laser welding process.