CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D
FDA premarket approval P010031/S167 · decided 2010-02-03
Approval details
- PMA number
- P010031
- Supplement
- S167
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-09-21
- Decision date
- 2010-02-03
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN MANUFACTURING TEST SOFTWARE AND TEST REQUIREMENTS.
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