FDA.reportPublic FDA data

Adapta™

Primary DI
00763000316778
Brand
Adapta™
Company
MEDTRONIC, INC.
Model
ADSR01P
Device description
IPG ADSR01P ADAPTA SR 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)
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3
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
00763000316778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000316778007630003167787630003167780763000316778

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable pacemaker, rate-responsiveA sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its 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 to provide 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
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169725379MyCareLink™MEDTRONIC, INC.NVZ2017-11-16
00643169871922Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871939Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871953Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-11-02
00643169871977Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169708600Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169708686Adapta™ LMEDTRONIC, INC.NVN2017-10-20
00643169708686Adapta™ LMEDTRONIC, INC.LWP2017-10-20
00643169709041Adapta™MEDTRONIC, INC.NVN2017-10-20
00643169709041Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169709065Sensia™MEDTRONIC, INC.LWP2017-10-20
00643169709072Versa™MEDTRONIC, INC.LWP2017-10-20
00643169720404Evera™ XT DRMEDTRONIC, INC.NVZ2017-09-15
00643169720497Evera MRI™ XT DR SureScan®MEDTRONIC, INC.NVZ2017-09-15
00643169720619Visia AF™ VRMEDTRONIC, INC.NVZ2017-09-15
00643169837713Evera MRI™ XT DR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169837744Evera MRI™ S DR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169837799Visa AF MRI™ VR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169988644Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2017-08-13
00643169708624Adapta™MEDTRONIC, INC.LWP2017-06-24
00643169708648Adapta™MEDTRONIC, INC.LWP2017-06-24
00643169708662Adapta™MEDTRONIC, INC.LWP2017-06-24