FDA.reportPublic FDA data

NA

Primary DI
00763000642082
Brand
NA
Company
MEDTRONIC, INC.
Model
PWC101
Device description
CORD PWC101 POWER CORD NORTH AMERICA
Published
2024-02-05
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
QZIPercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230017000PulseSelect™ Pulsed Field Ablation (PFA) systemMedtronic, Inc.2023-12-13QZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000642082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000642082007630006420827630006420820763000642082

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

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
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.QZI2026-04-30
05415067052933Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067053893Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067056009Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056016Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056023Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056030Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.QZI2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.QZI2026-02-08
00191506043964FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506047207FARAPOINT™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506047221FARAPOINT™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506055073FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506057688FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
05415067051417Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051516Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051554Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051615Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051721Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051752Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051813Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067052919Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067053022Volt™ PFA Sensor Enabled™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067053886Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067055903Volt™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067055910Volt™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067055927Volt™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067055934Volt™ST. JUDE MEDICAL, INC.QZI2026-01-06
07540162100277Globe® Catheter CableKardium IncQZI2025-09-15
07540162100321Globe® PF GeneratorKardium IncQZI2025-09-15