Identity
- Trade Name
- ACCOLADE™ SR FDA UDI
- Generic Name
- Single-chamber implantable pacemaker, rate-responsive FDA UDI
- Device Name
- Pacemaker FDA UDI
- Model / Reference
- L300 FDA UDI
- Description
- Pacemaker FDA UDI
Identifiers
- Catalog Number
- L300 FDA UDI
- Primary DI / UDI-DI
- 00802526559150 FDA UDI
- FDA Product Code
- LWP FDA UDI
- GMDN Term
- Single-chamber implantable pacemaker, rate-responsive 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Single-chamber implantable pacemaker, rate-responsive
Accolade™ Sr by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
N970003 also covers:
- ACCOLADE™ DR — Boston Scientific
- ACCOLADE™ EL DR — Boston Scientific
- ADVANTIO™ — Boston Scientific
- ADVANTIO™ — Boston Scientific
- ADVANTIO™ — Boston Scientific
- ALTRUA™ 2 DR — Boston Scientific
- ALTRUA™ 2 EL DR — Boston Scientific
- ALTRUA™ 2 SR — Boston Scientific
- ALTRUA™ 20 — Boston Scientific
- ALTRUA™ 20 — Boston Scientific
- ALTRUA™ 20 — Boston Scientific
- ALTRUA™ 20 — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI f65b1361-ae17-483a-b958-90db1c31d89b 35 fields · synced May 30, 2026