STRATOS LV/LV-T
FDA premarket approval P070008/S001 · decided 2008-11-04
Approval details
- PMA number
- P070008
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STRATOS LV/LV-T
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- Date received
- 2008-05-15
- Decision date
- 2008-11-04
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMW
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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 |