IMPLANT CONTROL SYSTEM (ICS) 3000
FDA premarket approval P950037/S035 · decided 2005-05-18
Approval details
- PMA number
- P950037
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMPLANT CONTROL SYSTEM (ICS) 3000
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 2003-07-28
- Decision date
- 2005-05-18
- Days to decision
- 660 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE IMPLANT CONTROL SYSTEM (ICS) 3000 PACEMAKER PROGRAMMING SYSTEM, USING SOFTWARE VERSION 402.U.
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510(k) clearances by this applicant
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