FDA.reportPublic FDA data

Innova™ Vascular

Primary DI
08714729873617
Brand
Innova™ Vascular
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939293052070
Catalog number
H74939293052070
Device description
Self-Expanding Stent System
Published
2015-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140028000
P140028010
P140028036
P140028053
P140028070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140028000INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMBoston Scientific Corporation2015-07-21NIP
P140028010INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMBoston Scientific Corporation2015-07-21NIP
P140028036INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMBoston Scientific Corporation2015-07-21NIP
P140028053INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMBoston Scientific Corporation2015-07-21NIP
P140028070INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMBoston Scientific Corporation2015-07-21NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729873617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729873617087147298736178714729873617

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506041656FARASTAR™M004PF41M434M004PF41M4342024-02-14
00191506041663FARASTAR™M004PF41M444M004PF41M4442024-02-09
08714729796695Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200002014-09-24
08714729802822Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200R02014-09-24
08714729961154Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200RR02017-08-07
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20705032082362S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082379S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082386S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
00733132645725GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645824GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645862GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645923GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645961GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646005GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646043GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646081GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646128GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
08717648225888SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225901SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225925SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225949SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225963SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225987SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226007SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226021SUPERAABBOTT VASCULAR INC.NIP2018-04-13