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Minima Stent System - 8mm

FDA UDI

Class III (US FDA UDI)

by Renata Medical, Inc.

Identity

Trade Name
Minima Stent System - 8mm FDA UDI
Generic Name
Bare-metal aortic stent FDA UDI
Device Name
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses. FDA UDI
Model / Reference
FG-0002 FDA UDI
Description
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses. FDA UDI

Identifiers

Primary DI / UDI-DI
00196852805037 FDA UDI
PMA Number
P240003 FDA UDI
FDA Product Code
PNF FDA UDI
QWC FDA UDI
GMDN Term
Bare-metal aortic stent 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bare-metal aortic stent

Minima Stent System - 8mm by Renata Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal aortic stent.

Cleared under the same submission

P240003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renata Medical, Inc.

Sources (1)

  • FDA UDI ae5d9544-9118-45a1-8208-38412f7919ae 34 fields · synced Jun 1, 2026