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Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA product code NHW · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.3680
Review panel
CV
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2002-05-24 – 2003-02-14

The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.

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