CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE
FDA premarket approval P950037/S053 · decided 2007-12-07
Approval details
- PMA number
- P950037
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2007-07-13
- Decision date
- 2007-12-07
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
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510(k) clearances by this applicant
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