VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P980016/S551 · decided 2016-01-19
Approval details
- PMA number
- P980016
- Supplement
- S551
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-30
- Decision date
- 2016-01-19
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE VISIA AF AND VISIA AF MRI SINGLE-CHAMBER (VR) ICD DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW035.
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