Basic Information

• Trade Name: MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276
• PMA Number: P980016
• Supplement Number: S016
• Advisory Committee: Cardiovascular
• Decision: Approved
• Decision Code: APPR
• Decision Date: May 25, 2001
• Date Received: February 5, 2001
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review: N

Advisory Committee Statement

APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.

Applicant

• Name: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Address: 8200 CORAL SEA STREET N.E., MS MVS11, MOUNDS VIEW, MN, 55112