Cleared Traditional

STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

K000029 · Ela Medical, Inc. · Cardiovascular

Apr 2000

Decision

90d

Days

Class 3

Risk

About This 510(k) Submission

K000029 is an FDA 510(k) clearance for the STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED 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 April 4, 2000, 90 days after receiving the submission on January 5, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number	K000029 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2000
Decision Date	April 04, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF