SELECTED FAMILIES OF ICD'S
FDA premarket approval P980016/S089 · decided 2006-11-29
Approval details
- PMA number
- P980016
- Supplement
- S089
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELECTED FAMILIES OF ICD'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-10-30
- Decision date
- 2006-11-29
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
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