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: FLEXTEND LEADS
• Classification Name: permanent pacemaker electrode
• Generic Name: transvenous bipolar pacing lead
• Regulation Number: 870.3680
• Applicant: GUIDANT CORP.
• PMA Number: P960006
• Supplement Number: S017
• Date Received: 08/01/2005
• Decision Date: 08/31/2005
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Addition of helix inspection criteria to the manufacturing instructions.