GUDID 00763000763817

SW APP P7A2P11 ALTAVIVA PATIENT

MEDTRONIC, INC.

Implantable electrical stimulation device management software
Primary Device ID00763000763817
NIH Device Record Key416ef9e0-ce11-45e8-a7be-80367d0e6dee
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberP7A2P11
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000763817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPTStimulator, tibial, electrical, implantable, for urinary incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-07
Device Publish Date2025-09-29

Devices Manufactured by MEDTRONIC, INC.

00763000763152 - NA2025-10-07 SW APP P7A2C11 ALTAVIVA CLINICIAN
00763000763817 - NA2025-10-07SW APP P7A2P11 ALTAVIVA PATIENT
00763000763817 - NA2025-10-07 SW APP P7A2P11 ALTAVIVA PATIENT
00763000929367 - Altaviva™2025-10-07 KIT P7K2C001 ALTAVIVA CLINICIAN
00763000935627 - Altaviva™2025-10-07 KIT P7K2P001 ALTAVIVA PATIENTA^
00763000936433 - Altaviva™2025-10-07 INS P7850N ALTAVIVA NEUROSTIMULATOR RC
00763000936440 - NA2025-10-07 ACCESSORY P71001 POCKET DISSECTOR
00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E

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