FDA.report

Affera™ Mapping System

Primary DI
00763000871956
Brand
Affera™ Mapping System
Company
MEDTRONIC, INC.
Model
AFR-00003
Device description
MAPPING SYSTEM AFR-00003 US
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications

CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions

SubmissionSupplement
K233943000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233943000Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)Medtronic, Inc.2024-03-08DQK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000871956PrimaryGS10

GMDN Terms

TermDefinition
Cardiac mapping systemAn assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00763000823795NAHY12A49R12023-01-15

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