CARDIAC AIRBAG
FDA premarket approval P980023/S021 · decided 2006-04-24
Approval details
- PMA number
- P980023
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARDIAC AIRBAG
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2006-03-10
- Decision date
- 2006-04-24
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ICS 3000 WITH IMPLANT MODULE.
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510(k) clearances by this applicant
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