FDA.reportPublic FDA data

Adapta™

Primary DI
00763000316730
Brand
Adapta™
Company
MEDTRONIC, INC.
Model
ADDR06
Device description
IPG ADDR06 ADAPTA DR UNI PARYCTD USA
Published
2020-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWPImplantable pulse generator, pacemaker (non-CRT)
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980035594

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980035594MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000316730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000316730007630003167307630003167300763000316730

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable pacemaker, rate-responsiveA sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

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
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWP2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25
00763000414030MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316723Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.NVZ2020-11-28
00763000316761Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316778Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316778Adapta™MEDTRONIC, INC.NVZ2020-11-28