Cleared Traditional

MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD

K880551 · Intermedics, Inc. · Cardiovascular
Mar 1988
Decision
27d
Days
Class 3
Risk

About This 510(k) Submission

K880551 is an FDA 510(k) clearance for the MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 7, 1988, 27 days after receiving the submission on February 9, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K880551 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1988
Decision Date March 07, 1988
Days to Decision 27 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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