← Back to catalogue

Promus PREMIER™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Promus PREMIER™ FDA UDI
Generic Name
Coronary angioplasty balloon catheter, basic FDA UDI
Device Name
Everolimus-Eluting Platinum Chromium Coronary Stent System FDA UDI
Model / Reference
H7493952824220 FDA UDI
Description
Everolimus-Eluting Platinum Chromium Coronary Stent System FDA UDI

Identifiers

Catalog Number
H7493952824220 FDA UDI
Primary DI / UDI-DI
08714729844822 FDA UDI
PMA Number
P110010 FDA UDI
FDA Product Code
NIQ FDA UDI
GMDN Term
Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Promus PREMIER™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P110010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI b722aaaa-96a6-4319-a2b0-609b37d7801a 37 fields · synced May 31, 2026