Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Evera S VR ICD,Evera XT DR ICD, Evera XT VR ICD,Protecta ICD, Protecta V
FDA premarket approval P980016/S651 · decided 2017-12-13
Approval details
- PMA number
- P980016
- Supplement
- S651
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Evera S VR ICD,Evera XT DR ICD, Evera XT VR ICD,Protecta ICD, Protecta V
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-11-29
- Decision date
- 2017-12-13
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Manufacturing process changes at a supplier for the 3um Complementary Metal Oxide Semiconductor (CMOS) components.
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