FDA.reportPublic FDA data

PACEART OPTIMA™ System

Primary DI
00643169345058
Brand
PACEART OPTIMA™ System
Company
MEDTRONIC, INC.
Model
POS12D13
Device description
SW POS12D13 PACEART OPTIMA MKT GLBL
Published
2016-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSELECTROCARDIOGRAPH
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
KREAnalyzer, Pacemaker Generator Function, IndirectCardiovascular2
OUGMedical Device Data SystemGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110693000PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.2011-06-08KRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169345058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169345058006431693450586431693450580643169345058

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit113 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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00199150044177Concerto Versa™CVP-152026-10-18
00199150044184Concerto Versa™CVP-302026-10-18
00199150044191Concerto Versa™CVP-402026-10-18
00199150044207Concerto Versa™CVP-652026-10-18
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21

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