CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
FDA premarket approval P010031/S169 · decided 2010-01-13
Approval details
- PMA number
- P010031
- Supplement
- S169
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-10-08
- Decision date
- 2010-01-13
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SWISS MANUFACTURING OPERATIONS IN TOLOCHENAZ, SWITZERLAND TO PERFORM FINAL PACKAGING FOR THE DEVICE.
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