ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS
FDA premarket approval P950037/S074 · decided 2010-01-22
Approval details
- PMA number
- P950037
- Supplement
- S074
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2009-11-24
- Decision date
- 2010-01-22
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL TO IMPLEMENT HARDWARE CHANGES TO THE ICS 3000 IMPLANT CONTROL SYSTEM.
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510(k) clearances by this applicant
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