FDA.reportPublic FDA data

Adapta™

Primary DI
00643169708624
Brand
Adapta™
Company
MEDTRONIC, INC.
Model
ADDR01
Device description
IPG ADDR01 ADAPTA DR IS-1 US NS
Published
2017-06-24
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
P980035475
P980035581
P980035594

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980035475MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ
P980035581MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ
P980035594MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169708624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169708624006431697086246431697086240643169708624

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
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316723Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316730Adapta™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
00763000316785Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316792Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000178338Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178345Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178451Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178468Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KGNVZ2020-09-15
00763000060060Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000316808Attesta™ DR MRI SureScan™MEDTRONIC, INC.LWP2020-07-30
00763000316815Attesta™ L DR MRI SureScan™MEDTRONIC, INC.NVZ2020-07-30
00763000316822Attesta™ S DR MRI SureScan™MEDTRONIC, INC.LWP2020-07-30