Cleared Traditional

INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG

K920530 · Intermedics, Inc. · Cardiovascular
Mar 1992
Decision
41d
Days
Class 3
Risk

About This 510(k) Submission

K920530 is an FDA 510(k) clearance for the INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on March 17, 1992, 41 days after receiving the submission on February 5, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K920530 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1992
Decision Date March 17, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXY — Implantable Pacemaker Pulse-generator
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3610

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