
Pacesetter Systems
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PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY is an FDA 510(k)-cleared medical device (K861422) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on June 25, 1986. Regulation: 8.

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