PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD
FDA premarket approval P980016/S280 · decided 2012-05-02
Approval details
- PMA number
- P980016
- Supplement
- S280
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-02-09
- Decision date
- 2012-05-02
- Days to decision
- 448 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC PROTECTA¿ XT VR D314VRM, PROTECTA¿ VR D334VRM, SECURA® VR D204VRM, MAXIMO II® VR D264VRM ICD SYSTEMS, MODEL 9995 APPLICATION SOFTWARE V7.3 AND MODEL SW009 APPLICATION SOFTWARE VL.0 SYSTEMS.
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