Cleared Traditional

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

K960281 · Intermedics, Inc. · Cardiovascular
Jun 1996
Decision
151d
Days
Class 3
Risk

About This 510(k) Submission

K960281 is an FDA 510(k) clearance for the IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on June 18, 1996, 151 days after receiving the submission on January 19, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K960281 FDA.gov
FDA Decision Cleared ST
Date Received January 19, 1996
Decision Date June 18, 1996
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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