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: INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P010015
• Supplement Number: S016
• Date Received: 10/06/2005
• Decision Date: 03/07/2006
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO DESCRIBE THE CARE-HF CLINICAL STUDY. MEDTRONIC ALSO REQUESTS A REFORMATTING OF THE INDICATIONS STATEMENT AND THE ADDITION OF A CLINICAL OUTCOMES SECTION TO THE DEVICE LABELING WHICH INCLUDES CLAIMS BASED ON THE PRIMARY ENDPOINT AND TWO SECONDARY ENDPOINTS IN THE CARE-HF STUDY. THE MEDTRONIC INSYNC III MODEL 8042 IS INDICATED FOR NYHA FUNCTIONAL CLASS III AND IV PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION. RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIENTS DEVELOPING A BRADYCARDIA INDICATION WHO MIGHT BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. DUAL CHAMBER AND ATRIAL TRACKING MODES ARE INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.