PROTECTA & PROTECTA XT CRT-DS
FDA premarket approval P010031/S249 · decided 2011-05-26
Approval details
- PMA number
- P010031
- Supplement
- S249
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTECTA & PROTECTA XT CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-04-25
- Decision date
- 2011-05-26
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
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