PMA P080006S062

Device

ATTTAIN ABILITY

Applicant

Medtronic, Inc.

PMA number

P080006

Supplement

S062

Product code

OJX

Decision date

2013-12-18

Classification

Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

Generic name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Approval order statement

UPDATE TO THE VALIDATED RANGES OF THE ELUTION AND DETERMINATION OF RELATED SUBSTANCES METHODS USED IN RELEASE TESTING ATTAIN ABILITY LEADS.

Summary

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