VARIOUS FAMILIES OF CRT/ICD'S
FDA premarket approval P010031/S081 · decided 2008-05-09
Approval details
- PMA number
- P010031
- Supplement
- S081
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF CRT/ICD'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-09-28
- Decision date
- 2008-05-09
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
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