PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD
FDA premarket approval P980016/S361 · decided 2012-09-10
Approval details
- PMA number
- P980016
- Supplement
- S361
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-11
- Decision date
- 2012-09-10
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PROTECTA ICD MODELS D334DRG, D334VRG; PROTECTA DF4 ICD MODELS D334DRM, D334VRM; PROTECTA XT ICD MODELS 0314DRG, D314VRG; PROTECTA XT DF4 ICD; MODELS D314DRM; AND D314VRM.
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