PMA P980016S353

Device

PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S

Applicant

Medtronic Cardiac Rhythm Disease Management

PMA number

P980016

Supplement

S353

Product code

LWS

Decision date

2012-06-13

Classification

Implantable Cardioverter Defibrillator (non-crt)

Generic name

Implantable cardioverter defibrillator (non-CRT)

Approval order statement

ALIGN HEADER MANUFACTURING PROCESSES OF THE PROTECTA XT VR (D314VRM), PROTECTA VR (D334VRM), SECURA VR (D204VRM) AND MAXMIO II VR (D264VRM) DF4 ICDS WITH CURRENTLY MANUFACTURED DEVICES.

Summary

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