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: SYMPHONY & ELA RHAPSODY DEVICES
• Classification Name: pulse generator, permanent, implantable
• Generic Name: implantable rate-responsive cardiac pacemaker & programmer
• Applicant: ELA MEDICAL, INC.
• PMA Number: P950029
• Supplement Number: S027
• Date Received: 08/18/2006
• Decision Date: 09/15/2006
• Product Code: NVZ [ Registered Establishments with NVZ ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in the flux used for solder rework.