FDA.report

ION™

Primary DI
08714729810599
Brand
ION™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493902424270
Catalog number
H7493902424270
Device description
Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NIQCoronary drug-eluting stent

Product Code Classifications

CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Premarket Submissions

SubmissionSupplement
P100023000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P100023000ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)Boston Scientific Corp2011-04-22NIQ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729810599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729810599087147298105998714729810599

GMDN Terms

TermDefinition
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coatedA non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24
08714729181163Percuflex™ BiliaryM005338502015-09-24
08714729181217Percuflex™ BiliaryM005336102015-09-24
08714729181224Percuflex™ BiliaryM005336202015-09-24
08714729181231Percuflex™ BiliaryM005336302015-09-24
08714729181248Percuflex™ BiliaryM005336402015-09-24
08714729181255Percuflex™ BiliaryM005336502015-09-24

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