CARDIOMESSENGER II
FDA premarket approval P950037/S054 · decided 2007-11-09
Approval details
- PMA number
- P950037
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARDIOMESSENGER II
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2007-08-13
- Decision date
- 2007-11-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR SOFTWARE, HARDWARE, PACKAGING AND LABELING MODIFICATIONS TO THE DEVICES.
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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 |
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