PALMAZ Balloon Expandable Stent

FDA UDI

Class III (US FDA UDI)

by Cordis US Corp.

Identity

Trade Name: PALMAZ Balloon Expandable Stent FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Model / Reference: P394 FDA UDI

Identifiers

Catalog Number: P394 FDA UDI
Primary DI / UDI-DI: 10705032076241 FDA UDI
PMA Number: P890017 FDA UDI
FDA Product Code: MAF FDA UDI
GMDN Term: Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Peripheral artery stent, bare-metal

PALMAZ Balloon Expandable Stent by Cordis US Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery stent, bare-metal.

Innova™ Vascular — Boston Scientific · Class III
Pulsar-18 — Biotronik, Inc. · Class III
LifeStent® Solo Vascular Stent — Bard Peripheral Vascular · Class III
Astron — Biotronik, Inc. · Class III
Absolute Pro — Abbott Vascular · Class III
Protégé™ GPS™ — EV3, INC · Class II
COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
Zilver 518 — Cook Ireland, Ltd. · Class III

Cleared under the same submission

P890017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Cordis US Corp.

Sources (1)

FDA UDI 60e2fb17-d5fb-4a5f-becc-92c574029746 35 fields · synced May 31, 2026