CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D
FDA premarket approval P010031/S467 · decided 2014-10-02
Approval details
- PMA number
- P010031
- Supplement
- S467
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-09-03
- Decision date
- 2014-10-02
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A BATTERY DESIGN CHANGE AND ASSOCIATED INSPECTION ANDPRODUCTION TOOLING CHANGES.
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