FDA.reportPublic FDA data

Maestro 3000™ Pod

Primary DI
08714729779896
Brand
Maestro 3000™ Pod
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00421870TR0
Device description
RF Cardiac Ablation Pod, 150W
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPBCardiac ablation percutaneous catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020025012
P020025014
P020025015
P020025018
P020025019
P020025020
P020025021
P020025026
P020025028
P020025029
P020025031
P020025036
P020025044
P020025045
P020025046
P020025049
P020025059
P020025061
P020025078

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020025012EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025014EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025015EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025018EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025019EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025020EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025021EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025026EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025028EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025029EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025031EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025036EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025044EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025045EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025046EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025049EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025059EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025061EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025078EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729779896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729779896087147297798968714729779896

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
04044508136959MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137031iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONLPB2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHLPB2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHLPB2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHLPB2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHLPB2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHLPB2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHLPB2024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)Stockert GmbHLPB2024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)Stockert GmbHLPB2024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)Stockert GmbHLPB2024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)Stockert GmbHLPB2024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)Stockert GmbHLPB2024-09-01
04260166374063INTELLAGEN™ RF GeneratorStockert GmbHLPB2024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbHLPB2024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbHLPB2024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbHLPB2024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbHLPB2024-09-01
00763000719265NAMEDTRONIC, INC.LPB2024-08-22
00763000719319NAMEDTRONIC, INC.LPB2024-08-22
00763000593889NAMEDTRONIC, INC.LPB2024-02-17