Cleared Traditional

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

K993448 · Ela Medical, Inc. · Cardiovascular

Apr 2000

Decision

181d

Days

Class 3

Risk

About This 510(k) Submission

K993448 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 10, 2000, 181 days after receiving the submission on October 12, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number	K993448 FDA.gov
FDA Decision	Cleared ST
Date Received	October 12, 1999
Decision Date	April 10, 2000
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—