Identity
- Trade Name
- ACUITY™ Steerable FDA UDI
- Generic Name
- Endocardial/interventricular septal pacing lead FDA UDI
- Device Name
- Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead FDA UDI
- Model / Reference
- 4554 FDA UDI
- Description
- Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526419324 FDA UDI
- PMA Number
- P050046 FDA UDI
- FDA Product Code
- NVY FDA UDI
- GMDN Term
- Endocardial/interventricular septal pacing lead 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
Yes
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: Endocardial/interventricular septal pacing lead
ACUITY™ Steerable by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P050046 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
- Boston Scientific
Sources (1)
- FDA UDI b10c0b38-8057-4471-a59e-55a7c5c72d7e 34 fields · synced May 30, 2026