BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01
FDA premarket approval P820076/S017 · decided 1995-09-07
Approval details
- PMA number
- P820076
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 1994-11-16
- Decision date
- 1995-09-07
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
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| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
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| 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 |