FDA.reportPublic FDA data

Paradym RF

Primary DI
08031527012278
Brand
Paradym RF
Company
MICROPORT CRM SRL
Model
CRT-D 9750
Published
2014-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060027032
P060027053
P060027070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060027032OVATIO CRT SYSTEMMicroPort CRM USA, Inc.2008-05-15NIK
P060027053OVATIO CRT SYSTEMMicroPort CRM USA, Inc.2008-05-15NIK
P060027070OVATIO CRT SYSTEMMicroPort CRM USA, Inc.2008-05-15NIK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527012278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527012278080315270122788031527012278

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable defibrillatorA sterile, implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08031527013909ECG Cable4,5m2014-09-05
08031527013916ECG Cable3m2014-09-05
08031527015057SPIDERVIEW / SPIDERFLASH2 Leads / 3E2016-09-22
08031527015064SPIDERVIEWXYZ-HR / 7E2016-09-22
08031527015071SPIDERVIEW12 Leads / 10 E2016-09-22
08031527015088SPIDERVIEW2 Leads / 5 E2016-09-22
08031527015095SPIDERVIEW3 Leads XYZ / 7E2016-09-22
08031527016023SPIDERVIEW7 leads2016-09-22
08031527019789VegaTLD040UTLD040U2023-06-23
08031527019796VegaTLD041UTLD041U2023-06-23
08031527019802VegaTLD042UTLD042U2023-06-23
08031527019611CPR4B10031B100312023-06-26
08031527019819VegaRLK40URLK40U2023-06-26
08031527019826VegaRLK41URLK41U2023-06-26
08031527019833VegaRLK42URLK42U2023-06-26
08031527018997BlueSkyTPM020UTPM020U2023-06-23
08031527019000BlueSkyTPM021UTPM021U2023-06-23
08031527019017BlueSkyTPM024UTPM024U2023-06-23
08031527019024BlueSkyTPM025UTPM025U2023-06-23
08031527019932SmartViewSW001USW001U2023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479182816Acticor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182854Rivacor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182861Rivacor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182984Rivacor Aura HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182991Rivacor Aura HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183028Rivacor Rise HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183035Rivacor Rise HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
05414734506380NAST. JUDE MEDICAL, INC.NIK2025-12-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.NIK2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NIK2024-11-13
05415067049513Entrant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067049520Gallant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067040404NAST. JUDE MEDICAL, INC.NIK2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.NIK2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NIK2022-08-29
00802526589744RESONATE™ HF CRT-DBOSTON SCIENTIFIC CORPORATIONNIK2021-07-12
05415067032812myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
00763000178093Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178109Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178130Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178147Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22