MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)
FDA premarket approval P980016/S337 · decided 2012-02-29
Approval details
- PMA number
- P980016
- Supplement
- S337
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-09
- Decision date
- 2012-02-29
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LWS
- 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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