Identity
- Trade Name
- Identity® FDA UDI
- Generic Name
- Dual-chamber implantable pacemaker, rate-responsive FDA UDI
- Device Name
- Pulse GeneratorVDDR FDA UDI
- Model / Reference
- 5480 FDA UDI
- Description
- Pulse GeneratorVDDR FDA UDI
Identifiers
- Catalog Number
- 5480 FDA UDI
- Primary DI / UDI-DI
- 05414734006927 FDA UDI
- PMA Number
- P880086 FDA UDI
- FDA Product Code
- DXY FDA UDI
- GMDN Term
- Dual-chamber implantable pacemaker, rate-responsive FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3610 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 8.5 Milliliter FDA UDI
Category: Dual-chamber implantable pacemaker, rate-responsive
Identity® by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dual-chamber implantable pacemaker, rate-responsive.
- Evity 6 DR-T — BIOTRONIK SE & Co. KG · Class III
- Azure™ S DR MRI SureScan™ — MEDTRONIC, INC. · Class III
- ESSENTIO™ EL DR — Boston Scientific · Class III
- Sensia™ — MEDTRONIC, INC. · Class III
- PROPONENT™ DR — Boston Scientific · Class III
- Attesta™ L DR MRI SureScan™ — MEDTRONIC, INC. · Class III
- Adapta™ — MEDTRONIC, INC. · Class III
- ALTRUA™ 40 — Boston Scientific · Class III
Cleared under the same submission
P880086 also covers:
- Accent® — ST. JUDE MEDICAL, INC.
- Accent™ — ST. JUDE MEDICAL, INC.
- Accent™ — ST. JUDE MEDICAL, INC.
- Accent™ — ST. JUDE MEDICAL, INC.
- Assurity™ — ST. JUDE MEDICAL, INC.
- Assurity™ — ST. JUDE MEDICAL, INC.
- Assurity™ — ST. JUDE MEDICAL, INC.
- Assurity™ — ST. JUDE MEDICAL, INC.
- Endurity™ — ST. JUDE MEDICAL, INC.
- Endurity™ — ST. JUDE MEDICAL, INC.
- Identity® — ST. JUDE MEDICAL, INC.
- Identity™ — ST. JUDE MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI ab3af875-a16a-4644-8ebf-2b73bc943775 38 fields · synced Jun 7, 2026