Basic Information

• Trade Name: CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D
• PMA Number: P010031
• Supplement Number: S339
• Advisory Committee: Cardiovascular
• Decision: 30-Day Notice Accepted
• Decision Code: OK30
• Decision Date: November 16, 2012
• Date Received: October 19, 2012
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.

Applicant

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