Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CELLSIUS INTERFACE CABLES (AUTOCLAVABLE)
• Generic Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Regulation Number: 870.1220
• Applicant: Biosense Webster, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P950005
• Supplement Number: S006
• Date Received: 08/02/1999
• Decision Date: 02/01/2000
• Product Code: DRF
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No