Identity
- Trade Name
- Sustain™ FDA UDI
- Generic Name
- Single-chamber implantable pacemaker, rate-responsive FDA UDI
- Device Name
- Pulse GeneratorSSIR FDA UDI
- Model / Reference
- PM1136 FDA UDI
- Description
- Pulse GeneratorSSIR FDA UDI
Identifiers
- Catalog Number
- PM1136 FDA UDI
- Primary DI / UDI-DI
- 05414734504737 FDA UDI
- PMA Number
- P880086 FDA UDI
- FDA Product Code
- NVZ 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
Dimensions & Sizes
- Size
- Total Volume — 10.4 Milliliter FDA UDI
Category: Single-chamber implantable pacemaker, rate-responsive
Sustain™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI f84b3d59-c3db-446c-ba19-1fde6e0fcdba 38 fields · synced May 30, 2026