RELIATY / MODEL 3145 PACING SYSTEM
FDA premarket approval P950037/S109 · decided 2012-08-28
Approval details
- PMA number
- P950037
- Supplement
- S109
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIATY / MODEL 3145 PACING SYSTEM
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Applicant
- Biotronik, Inc.
- Date received
- 2012-06-18
- Decision date
- 2012-08-28
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- OVJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR FIRMWARE MODIFICATIONS AND LABELING UPDATES TO THE DEVICES.
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510(k) clearances by this applicant
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