DeviceClearance

Product code NHW— Cardiovascular

GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM

Classification name
Electrode, Pacing And Cardioversion, Temporary, Epicardial
Device class
Class 2
Regulation
21 CFR 870.3680
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code NHW under 21 CFR 870.3680, via openFDA

Market context for product code NHW

FDA has cleared 2 devices under product code NHW between 2002 and 2003, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHW

Recent clearances under product code NHW

Data sourced from openFDA. This site is unofficial and independent of the FDA.