FDA.reportPublic FDA data

PALMAZ Balloon Expandable Stent

Primary DI
20705032057223
Brand
PALMAZ Balloon Expandable Stent
Company
CORDIS CORPORATION
Model
P104
Catalog number
P104
Published
2015-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAFSTENT, CORONARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890017015

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890017015PALMAZ BALLOON EXPANDABLE STENTCordis US Corporation1991-09-27NIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032057223PackageGS14In Commercial Distribution
10705032076227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205722320705032057223
1070503207622710705032076227

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894588002125Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002132Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002149Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002156Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002163Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002170Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002187Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
10705032064736PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076197PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076234PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076241PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
20705032057285PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057261PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057247PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057346PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
10705032076227PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-04-29
08714729203940WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203957WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203964WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203971WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203988WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203995WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204008WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204015WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204022WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204039WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204046WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204053WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406433WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406457WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24