Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi
FDA premarket approval P980016/S654 · decided 2017-12-21
Approval details
- PMA number
- P980016
- Supplement
- S654
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-12-12
- Decision date
- 2017-12-21
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Elimination of a destructive in-process manual peel test monitor performed after first shot assembly of the connector module.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.