FDA.reportPublic FDA data

Synergy™ Ablation System

Primary DI
00818354010206
Brand
Synergy™ Ablation System
Company
ATRICURE, INC.
Model
ASU2
Catalog number
A000019
Device description
Ablation and Sensing Unit
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100046003
P100046004
P100046005
P100046006
P100046007
P100046008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100046003ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM
P100046004ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM
P100046005ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM
P100046006ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM
P100046007ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM
P100046008ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818354010206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354010206008183540102068183540102060818354010206

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system generatorA mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius54 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-349-2342xxx@xxx.xxx

Regulatory Flags#

DUNS number
006133784
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO235A0009652026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO240A0009662026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO245A0009672026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO250A000968 2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30840143913703Multifunctional Ablation GeneratorATRICURE, INC.OCM2026-05-27
10840143913761Isolator Synergy™ ATRICURE, INC.OCM2026-05-12
10840143907807EPi-Sense Guided Coagulation SystemATRICURE, INC.OCM2026-04-23
10840143907845Subtle Cannula with Guide ATRICURE, INC.OCM2026-04-23
10840143907852Cannula with GuideATRICURE, INC.OCM2026-04-23
10840143909375EPi-Sense Guided Coagulation SystemATRICURE, INC.OCM2026-04-23
10840143909382EPi-Sense ST Guided Coagulation SystemATRICURE, INC.OCM2026-04-23
10840143913273EPi-Sense STATRICURE, INC.OCM2026-04-23
10840143913884EPi-Sense STATRICURE, INC.OCM2026-04-23
30840143902950Isolator Surgical Ablation SystemATRICURE, INC.OCM2026-02-06
10840143901553Isolator Surgical Ablation SystemATRICURE, INC.OCM2026-02-06
30840143904473Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143900044Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143901485Coagulation RF cableATRICURE, INC.OCM2022-09-23
10840143904585EPi-Sense ST Coagulation Device ATRICURE, INC.OCM2022-09-23
30840143901663Coagulation RF cableATRICURE, INC.OCM2022-09-23
10840143901607Cannula with GuideATRICURE, INC.OCM2022-09-23
30840143901656EPi-Sense ST Coagulation Device ATRICURE, INC.OCM2022-09-23
10840143904530Coagulation RF CableATRICURE, INC.OCM2021-05-24
10840143904547Subtle Cannula with Guide ATRICURE, INC.OCM2021-05-24
10840143904578nContact RF GeneratorATRICURE, INC.OCM2021-05-24
30840143903803Coagulation RF CableATRICURE, INC.OCM2021-05-24
30840143903810Subtle Cannula with Guide ATRICURE, INC.OCM2021-05-24
10840143904554EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.OCM2021-05-24
10840143904561nContact RF GeneratorATRICURE, INC.OCM2021-05-24
30840143902134nContact RF GeneratorATRICURE, INC.OCM2021-05-24
10840143901584Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-11
30840143903018Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-11
10840143904028Ablation Sensing Unit ATRICURE, INC.OCM2021-01-11
10840143902109Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-08