Platinium

FDA UDI

Class III (US FDA UDI)

by Microport Crm Srl

Identity

Trade Name: PLATINIUM FDA UDI
Generic Name: Dual-chamber implantable defibrillator FDA UDI
Model / Reference: DR 1510 FDA UDI

Identifiers

Primary DI / UDI-DI: 08031527015521 FDA UDI
PMA Number: P980049 FDA UDI
FDA Product Code: MRM FDA UDI
GMDN Term: Dual-chamber implantable defibrillator 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dual-chamber implantable defibrillator

Platinium by Microport Crm Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dual-chamber implantable defibrillator.

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INOGEN™ EL ICD DR — Boston Scientific · Class III
Fortify Assura™ — ST. JUDE MEDICAL, INC. · Class III
Current™ — ST. JUDE MEDICAL, INC. · Class III
Cobalt™ XT DR MRI SureScan™ — MEDTRONIC, INC. · Class III

Cleared under the same submission

P980049 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: Microport Crm Srl

Sources (1)

FDA UDI bfbb6d1a-1830-4d16-963c-cf10e09765db 33 fields · synced May 30, 2026