Cleared Traditional

8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS

K911122 · Intermedics, Inc. · Cardiovascular
May 1991
Decision
65d
Days
Class 3
Risk

About This 510(k) Submission

K911122 is an FDA 510(k) clearance for the 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on May 16, 1991, 65 days after receiving the submission on March 12, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K911122 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1991
Decision Date May 16, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

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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