Identity
- Trade Name
- Sentus ProMRI OTW QP S-75 FDA UDI
- Generic Name
- Coronary venous pacing lead FDA UDI
- Model / Reference
- 401179 FDA UDI
Identifiers
- Catalog Number
- 401179 FDA UDI
- Primary DI / UDI-DI
- 04035479138400 FDA UDI
- PMA Number
- P070008 FDA UDI
- FDA Product Code
- OJX FDA UDI
- GMDN Term
- Coronary venous 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
MR Conditional FDA UDI
Category: Coronary venous pacing lead
Sentus ProMRI OTW QP S-75 by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary venous pacing lead.
- Attain Ability™ Straight MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Performa™ MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Ability™ Straight MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Stability™ Quad MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Performa™ S MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Stability™ Quad MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Performa™ MRI SureScan™ — MEDTRONIC, INC. · Class III
- Attain Ability™ MRI SureScan™ — MEDTRONIC, INC. · Class III
Cleared under the same submission
P070008 also covers:
- CELERITY — BIOTRONIK SE & Co. KG
- CELERITY — BIOTRONIK SE & Co. KG
- CELERITY — BIOTRONIK SE & Co. KG
- CELERITY — BIOTRONIK SE & Co. KG
- CELERITY — BIOTRONIK SE & Co. KG
- CELERITY — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
- Corox — BIOTRONIK SE & Co. KG
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
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI 994d17d7-4d5b-4704-be5e-f759e3ea0660 36 fields · synced May 30, 2026