FDA.reportPublic FDA data

Altius Patient Controller

Primary DI
00810118490026
Brand
Altius Patient Controller
Company
Neuros Medical, Inc.
Model
FG-604-000
Published
2024-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower LimbUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230020000Altius® Direct Electrical Nerve Stimulation SystemNeuros Medical, Inc.2024-08-26SAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810118490026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118490026008101184900268101184900260810118490026

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unitA portable, external, electrically-powered component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to be used by a patient to telemetrically control its function (on/off) for delivery of treatment cycles. The system is designed to deliver episodic electrical stimulation to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for the relief/treatment of acute and/or chronic intractable pain [e.g., chronic low back pain (CLBP)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829526081
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118490019Altius Battery ChargerFG-603-0002024-12-23
00810118490101Altius IPG Accessory KitFG-610-0002025-06-23
00810118490002Altius IPGFG-601-0002024-12-23
00810118490057Altius Programmer WandFG-606-0002024-12-23
00810118490064Altius Programming Application PCFG-608-0002024-12-23
00810118490071Altius Cuff SmallFG-600-0012024-12-23
00810118490088Altius Cuff MediumFG-600-0022024-12-23
00810118490095Altius Cuff LargeFG-600-0032024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118490101Altius IPG Accessory KitNeuros Medical, Inc.SAZ2025-06-23
00810118490002Altius IPGNeuros Medical, Inc.SAZ2024-12-23
00810118490019Altius Battery ChargerNeuros Medical, Inc.SAZ2024-12-23
00810118490057Altius Programmer WandNeuros Medical, Inc.SAZ2024-12-23
00810118490064Altius Programming Application PCNeuros Medical, Inc.SAZ2024-12-23
00810118490071Altius Cuff SmallNeuros Medical, Inc.SAZ2024-12-23
00810118490088Altius Cuff MediumNeuros Medical, Inc.SAZ2024-12-23
00810118490095Altius Cuff LargeNeuros Medical, Inc.SAZ2024-12-23