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: CARBON TIP CARDIAC PACING LEAD
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: Pacesetter Systems; 15900 Valley View Ct.; P.O. Box 9221; Sylmar, CA 91392
• PMA Number: P800041
• Supplement Number: S015
• Date Received: 10/02/1995
• Decision Date: 01/04/1996
• Product Code: DTB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE ADDITION OF A "NITROGEN BLANKET" TO STERILIZATION PROCESS