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Frontier™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Frontier™ FDA UDI
Generic Name
Cardiac resynchronization therapy implantable pacemaker FDA UDI
Device Name
Cardiac Resynchronization Therapy Pacemaker (CRT-P) DDDRV FDA UDI
Model / Reference
II FDA UDI
Description
Cardiac Resynchronization Therapy Pacemaker (CRT-P) DDDRV FDA UDI

Identifiers

Catalog Number
5586 FDA UDI
Primary DI / UDI-DI
05414734502948 FDA UDI
PMA Number
P030035 FDA UDI
FDA Product Code
NKE FDA UDI
GMDN Term
Cardiac resynchronization therapy implantable pacemaker 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 11.5 Milliliter FDA UDI

Frontier™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P030035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI a66324c8-6bc8-49e4-8913-b9d5693cb628 39 fields · synced Jun 1, 2026