Cleared Traditional

K972574 - STELA MODEL UJ45 PACING LEADS
(FDA 510(k) Clearance)

K972574 · Ela Medical, Inc. · Cardiovascular

Jan 1998

Decision

182d

Days

Class 3

Risk

K972574 is an FDA 510(k) clearance for the STELA MODEL UJ45 PACING LEADS, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 8, 1998, 182 days after receiving the submission on July 10, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number	K972574 FDA.gov
FDA Decision	Cleared ST
Date Received	July 10, 1997
Decision Date	January 08, 1998
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—