FDA.reportPublic FDA data

N/A

Primary DI
00763000520083
Brand
N/A
Company
MEDTRONIC, INC.
Model
A71200
Device description
SW APP A71200 SCS CLINICIAN NG PAIN PC
Published
2021-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
P840001471
P840001499
P840001594
P840001623

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840001471ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P840001499ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P840001594ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P840001623ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000520083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000520083007630005200837630005200830763000520083

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.

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729931492NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-05-03
08714729905325Clik™ X MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729907091Precision Montage™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729931775Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729904816Avista™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729904823Avista™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729905387Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729905936Precision™ Montage™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729905943Precision™ Montage™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729907077Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729907114Precision Montage ™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2016-05-03
08714729763352Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-02-23
08714729789697Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729789703Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729121763Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2015-12-23
08714729121695Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2015-12-23
08714729789550Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2015-12-15