EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES
FDA premarket approval P950037/S154 · decided 2015-06-12
Approval details
- PMA number
- P950037
- Supplement
- S154
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2015-05-19
- Decision date
- 2015-06-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- CHANGE TO THE SPRING BUSHINGS USED IN THE DEVICE HEADER AND THE ASSOCIATED MANUFACTURING EQUIPMENT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706) | Biotronik, Inc. | 2025-04-04 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787) | Biotronik, Inc. | 2024-09-12 |
| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |