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: LINOX LEAD FAMILY
• Classification Name: permanent defibrillator electrodes
• Generic Name: implantable cardioverter defibrillator
• Applicant: BIOTRONIK, INC.
• PMA Number: P980023
• Supplement Number: S048
• Date Received: 09/10/2012
• Decision Date: 10/10/2012
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Addition of suppliers for components used in the devices.