RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS
FDA premarket approval P950037/S088 · decided 2011-04-20
Approval details
- PMA number
- P950037
- Supplement
- S088
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Applicant
- Biotronik, Inc.
- Date received
- 2010-10-06
- Decision date
- 2011-04-20
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- OVJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE; 7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES.
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510(k) clearances by this applicant
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| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
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