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FDA 510(k) Application Details - K000763
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K000763
Device Name
Permanent Pacemaker Electrode
Applicant
BIOTRONIK, GMBH & CO.
6024 JEAN RD.
LAKE OSWEGO, OR 97035 US
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Contact
Jon Brumbaugh
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
DTB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2000
Decision Date
04/06/2000
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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