FDA.reportPublic FDA data

NA

Primary DI
00763000875749
Brand
NA
Company
MEDTRONIC, INC.
Model
97745FA-RFB
Device description
PROG 97745FA INTELLIS PTM REFURB US
Published
2023-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGWStimulator, spinal-cord, totally implanted for pain relief
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840001344

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840001344ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000875749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000875749007630008757497630008757490763000875749

GMDN Terms#

Term, Definition table
TermDefinition
Multiple active implantable device programmerAn external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius58 Degrees Celsius
Storage Environment Temperature-22 Degrees Fahrenheit136 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796986144
Device count
1
Serial number
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
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729960713NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729960720NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729951124Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951131Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729951254Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952046Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953432Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952053Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953449Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953487Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935087Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935094Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729954385NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729954392NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729950684Entrada ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-04