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Biotronik, GmbH & Co.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K000763 PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051DTB2000-04-06 View
510(k) K923406 BIOSCOPEDPS1993-09-22 View
510(k) K923026 PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERDXY1993-08-19 View
510(k) K922742 HPM 40 HEART PACEMAKER MONITORKRE1993-03-18 View
510(k) K914109 PIKOS 01 & PIKOS E 01DXY1992-02-26 View
510(k) K910609 PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIPDTB1991-08-28 View
510(k) K911142 LEAD TERMINAL PIN CAPS, VARIOUS MODELSDTD1991-08-09 View
510(k) K910608 PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIPDTB1991-07-30 View
510(k) K905087 TRIOS 02DXY1991-05-07 View
510(k) K903929 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UPDTB1990-10-16 View
510(k) K903928 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UPDTB1990-10-16 View
510(k) K903927 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UPDTB1990-10-16 View
510(k) K903081 NEOS (TM) 02 B PULSE GENERATORDXY1990-09-14 View
510(k) K902889 A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.DTD1990-08-23 View
510(k) K896824 BIOTRONIK'S PS-ENDOCARDIAL LEADSDTB1990-08-08 View
510(k) K901709 DNP 60-B UNIPOLAR ENDOCARDIAL LEADDTB1990-05-22 View
510(k) K901332 PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGEDTC1990-05-09 View
510(k) K894494 LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEADDXY1989-10-17 View
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