FDA.reportPublic FDA data

Altaviva™

Primary DI
00763000763190
Brand
Altaviva™
Company
MEDTRONIC, INC.
Model
P742A1
Device description
ANKLE BAND P742A1 ALTAVIVA
Published
2025-10-02
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
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
00763000763190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000763190007630007631907630007631900763000763190

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, belt or strap intended to pass through the bag’s slots, headband, clothing, or trolley with wheels. This is a reusable device.

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
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
00643169559981Euphora™EUP22525X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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