IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM
FDA premarket approval P000009/S042 · decided 2011-04-15
Approval details
- PMA number
- P000009
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2010-10-28
- Decision date
- 2011-04-15
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
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510(k) clearances by this applicant
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