FDA.reportPublic FDA data

Symplicity Spyral™

Primary DI
00763000354466
Brand
Symplicity Spyral™
Company
MEDTRONIC, INC.
Model
RDN016
Device description
SPYRAL CATHETER RDN016 US COMMERCIAL
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00763000354466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000354466007630003544667630003544660763000354466

GMDN Terms#

Term, Definition table
TermDefinition
Renal denervation radio-frequency ablation catheterA sterile, steerable, thin, flexible tube containing one or more monopolar electrodes intended to be introduced percutaneously into the renal artery to transmit precisely-focused, low-level, radio-frequency (RF) current, from a connected RF generator, to disrupt renal nerves for therapeutic denervation of the kidney; commonly known as renal denervation (RDN). The device has embedded metallic electrodes and may be available in a variety of forms (e.g., deflectable tip, balloon catheter). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric Pressure30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure595 millibar1060 millibar
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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

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
00763000387020Symplicity G3™MEDTRONIC, INC.QYI2023-11-30