FDA.reportPublic FDA data

SUPERA

Primary DI
08717648225963
Brand
SUPERA
Company
ABBOTT VASCULAR INC.
Model
S-45-080-120-P6
Catalog number
S-45-080-120-P6
Device description
Supera Peripheral Stent System 4.5 mm x 80 mm x 120 cm 6 F
Published
2018-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08975370026252PreviousGS10
08717648225963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08975370026252089753700262528975370026252
08717648225963087176482259638717648225963

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from Direct Sunlight, Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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