Alair Bronchial Thermoplasty RF Controller

Primary DI
08714729796695
Brand
Alair Bronchial Thermoplasty RF Controller
Company
BOSTON SCIENTIFIC CORPORATION
Model
ATS 200
Catalog number
M005ATS20000
Device description
Alair BT Controller
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOYBronchial thermoplasty system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOYBronchial Thermoplasty SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080032000
P080032015
P080032016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080032000ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032015ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032016ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729796695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729796695087147297966958714729796695

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729961154Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONOOY2017-08-07
08714729802778Alair™BOSTON SCIENTIFIC CORPORATIONOOY2014-09-24
08714729802792ALAIR™BOSTON SCIENTIFIC CORPORATIONOOY2014-09-24
08714729802822Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONOOY2014-09-24