FDA.reportPublic FDA data

NA

Primary DI
00763000763817
Brand
NA
Company
MEDTRONIC, INC.
Model
P7A2P11
Device description
SW APP P7A2P11 ALTAVIVA PATIENT
Published
2025-09-29
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
QPTStimulator, tibial, electrical, implantable, for urinary incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPTStimulator, Tibial, Electrical, Implantable, For Urinary IncontinenceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240011000Medtronic Altaviva SystemMedtronic Neuromodulation2025-09-18QPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000763817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000763817007630007638177630007638170763000763817

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

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
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000763190Altaviva™MEDTRONIC, INC.QPT2025-10-02
00763000934132NAMEDTRONIC, INC.QPT2025-10-02
00763000929374NAMEDTRONIC, INC.QPT2025-10-02
00763000763152NAMEDTRONIC, INC.QPT2025-09-29
00763000929367Altaviva™MEDTRONIC, INC.QPT2025-09-29
00763000935627Altaviva™MEDTRONIC, INC.QPT2025-09-29
00763000936433Altaviva™MEDTRONIC, INC.QPT2025-09-29
00860007896972eCoin External Controller KitValencia Technologies CorporationQPT2023-04-27
00860007896903eCoin Device KitValencia Technologies CorporationQPT2022-04-28
00860007896910eCoin External Controller KitValencia Technologies CorporationQPT2022-04-28
00860007896965eCoin Patient KitValencia Technologies CorporationQPT2022-04-28