FDA.reportPublic FDA data

Symplicity G3™

Primary DI
00763000387020
Brand
Symplicity G3™
Company
MEDTRONIC, INC.
Model
RDNG3A
Device description
GENERATOR RDNG3A G3SV5.1 US JP CA
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYIAblation catheter, renal denervation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYIAblation Catheter, Renal DenervationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220026000Symplicity Spyral™ Renal Denervation SystemMedtronic, Inc.2023-11-17QYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000387020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000387020007630003870207630003870200763000387020

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure595 millibar1060 millibar
Storage Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius57 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810008950005Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950012Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950029Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950036Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950043Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950050Paradise® Connection CableRecor Medical, Inc.QYI2023-12-11
00810008950067Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950074Paradise® CartridgeRecor Medical, Inc.QYI2023-12-11
00810008950098Paradise® RemoteRecor Medical, Inc.QYI2023-12-11
00810008950111Paradise® GeneratorRecor Medical, Inc.QYI2023-12-11
00810008950128Paradise® GeneratorRecor Medical, Inc.QYI2023-12-11
00763000354466Symplicity Spyral™MEDTRONIC, INC.QYI2023-11-30