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: STELID II BFT/BJF/STELIX BR/STELIX II BRF
• Classification Name: permanent defibrillator electrodes
• Generic Name: endocardial pacing lead
• Applicant: ELA MEDICAL, INC.
• PMA Number: P020030
• Supplement Number: S008
• Date Received: 03/02/2011
• Decision Date: 03/31/2011
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Update to the current leads label printing software.