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: INTERFACE CABLES
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: radiofrequency generator and accessories/accessory cable
• Applicant: BIOSENSE WEBSTER, INC.
• PMA Number: P990071
• Supplement Number: S015
• Date Received: 09/08/2011
• Decision Date: 10/07/2011
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Parametric release of sterilized product using ethylene oxide.