FDA.reportPublic FDA data

Altaviva™

Primary DI
00763000936433
Brand
Altaviva™
Company
MEDTRONIC, INC.
Model
P7850N
Device description
INS P7850N ALTAVIVA NEUROSTIMULATOR RC
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
00763000936433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000936433007630009364337630009364330763000936433

GMDN Terms#

Term, Definition table
TermDefinition
Implantable incontinence-control electrical stimulation system pulse generatorA sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.

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
Serial number
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
00763000763817NAMEDTRONIC, INC.QPT2025-09-29
00763000929367Altaviva™MEDTRONIC, INC.QPT2025-09-29
00763000935627Altaviva™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