Basic Information

• Trade Name: CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D. PROTECTA XT CRT-D
• PMA Number: P010031
• Supplement Number: S338
• Advisory Committee: Cardiovascular
• Decision: 30-Day Notice Accepted
• Decision Code: OK30
• Decision Date: November 7, 2012
• Date Received: October 9, 2012
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

Approval for 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.

Applicant

• Name: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Address: 8200 CORAL SEA STREET N.E., MOUNDS VIEW, MN, 55112