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: MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P920015
• Supplement Number: S021
• Date Received: 02/05/2001
• Decision Date: 06/11/2001
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE MODEL 6996 SQ LEAD SYSTEM AND THE 6996T TUNNELING TOOL. THE MODEL 6996 SQ LEAD SYSTEM IS FOR SINGLE, LONG-TERM SUBCUTANEOUS USE AND IS INTENDED FOR USE IN PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) ARE INDICATED. THE LEAD IS INTENDED FOR USE IF A STANDARD ICD SYSTEM WITH ONE OR TWO TRANSVENOUS LEADS HAS NOT BEEN EFFICACIOUS IN PROVIDING ACCEPTABLE DFT MEASUREMENTS. THE MODEL 6996 SQ LEAD IS INTENDED FOR USE ONLY WITH THE FOLLOWING SYSTEMS: A MEDTRONIC ICD FEATURING A CONNECTOR BLOCK WITH AT LEAST TWO DF-1 CONNECTOR PORTS; AND A MEDTRONIC RIGHT VENTRICULAR LEAD FOR DEFIBRILLATING/PACING/SENSING. IN ADDITION, A THIRD DEFIBRILLATION LEAD, SUCH AS ANY MEDTRONIC SVC LEAD, MAY BE USED WITH A LEAD ADAPTOR.