ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY
FDA premarket approval P950037/S017 · decided 2001-05-24
Approval details
- PMA number
- P950037
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2000-09-27
- Decision date
- 2001-05-24
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE USE OF THE LITRONIK BATTERY MODEL LIS 3150 IN THE ACTROS+ AND KAIROS PULSE GENERATOR FAMILIES.
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510(k) clearances by this applicant
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| 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 |