Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D
FDA premarket approval P980016/S602 · decided 2016-10-24
Approval details
- PMA number
- P980016
- Supplement
- S602
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-26
- Decision date
- 2016-10-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Extension of a continuous monitoring system for non-controlled manufacturing areas.
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