PMA P980016S715
- Device
- Evera, S, XT, DR, VR, Mirro, Primo MRI, DR, VR; Protecta VR, XT; Secura; Visia AF, MRI, VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S715
- Product code
- LWS
- Decision date
- 2019-07-22
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the incoming inspection and component specification for TiO2 pigment paste.
Current openFDA PMA Record#
- Device
- Evera, S, XT, DR, VR, Mirro, Primo MRI, DR, VR; Protecta VR, XT; Secura; Visia AF, MRI, VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S715
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-07-22
- Decision code
- OK30
- Date received
- 2019-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the incoming inspection and component specification for TiO2 pigment paste.