PMA P960013S100

Device

Tendril SDX, OptiSense, Tendril STS and Tendril ST

Applicant

ABBOTT MEDICAL

PMA number

P960013

Supplement

S100

Product code

NVN

Decision date

2018-07-19

Classification

Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes

Generic name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Approval order statement

Change the cleaning agent and cleaning process on the incoming tools used in the manufacture of MCRDs.

Summary

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