
Pacesetter, Inc.
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TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD is an FDA 510(k)-cleared medical device (K951087) manufactured by Pacesetter, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on June 28, 1995. Regulation: 8.

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