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Home›USA›ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION

USA · Sylmar
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
12510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 12 510(k), 2,726 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
30 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
46active device licences
Class II 3Class III 1Class IV 42
91 including historic records
TWTaiwanTFDA
25valid device licences
Class II 7Class III 18
SGSingaporeHSA SMDR
5device registrations
CLASS B 1CLASS C 1CLASS D 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
57active ARTG entries
Class I 2Class III 43IIa 2IIb 4Class Is (sterile) 6
HKHong KongMDACS
9valid listings
Class III 1Class IV 8
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 1Class 3 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 12 510(k), 2,726 PMA, 6 excluded
Brazil1 confirmed, 0 excluded
Canada46 confirmed, 1 excluded
Manufacturer names merged into this page: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION · ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Same-named companies — This database also contains companies with near-identical names: Medtronic Inc. Cardiac Rhythm Management. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Sylmar

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12004
12007
22008
22009
12010
22011
32012

Registration details (sample)

MarketIdentifierNameClass / date
USK122090SJM CONFIRM IMPLANTABLE CARDIAC MONITOR2012-11-15
USK120296CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER2012-05-11
USK120298CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE2012-05-08
BR10332340052CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803Class II
CA189AFFINITY PULSE GENERATORSClass IV
CA528PROFILE IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEMClass IV
CA583VENTRITEX PR 1500 PROGRAMMERClass IV

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