MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)
FDA premarket approval P010031/S290 · decided 2012-02-29
Approval details
- PMA number
- P010031
- Supplement
- S290
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-09
- Decision date
- 2012-02-29
- Days to decision
- 20 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FOUR MANUFACTURING CHANGES: 1) RF MODULE SOLDER FLUX CLEAN ADDITION; 2) FLUX INSPECTION CHANGE; 3) RADIO FREQUENCY DEVICE TEST UPDATE; AND 4) A MANUFACTURING SITE MOVE FOR 8-PIN FILTERS.
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