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FDA 510(k) Application Details - K980869
Device Classification Name
Permanent Pacemaker Electrode
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510(K) Number
K980869
Device Name
Permanent Pacemaker Electrode
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
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DAVID MAKANANI
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Regulation Number
870.3680
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Classification Product Code
DTB
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More FDA Info for this Product Code
Date Received
03/06/1998
Decision Date
09/10/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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