MEDTRONIC FABRICATION S.A.S.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9611350	1000241540	MEDTRONIC FABRICATION S.A.S.	1	N	2026-01-01	103 ROUTE D ANOR FOURMIES Nord FR 59610

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5823	1426039027	K973360	MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD	LDF	1998-05-26
5823	2006680668	K190716	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead	LDF	2019-08-08
5823	1626645316	K171253	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead	LDF	2017-05-25
5823	1576982904	K161249	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	LDF	2016-08-19
5823	1346655005	K140972	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING	LDF	2014-06-06
5823	1738326790	K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	LDF	2004-09-07
5823	1002511704	K012460	MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD	LDF	2001-08-14
5823	1541884038	K012459	MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE	LDF	2001-08-14
5823	1997256456	K012458	MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD	LDF	2001-08-14
5823	1263986609	K012454	MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD	LDF	2001-08-14
5823	1394654529	K012452	MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD	LDF	2001-08-14

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LDF	11	2019-08-08