PMA P980016S684
- Device
- Protecta ICD, Protecta VR ICD, and Protecta XT ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S684
- Product code
- LWS
- Decision date
- 2018-09-05
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the Titan Device Level Final Functional Tester for the Protecta family devices.
Current openFDA PMA Record#
- Device
- Protecta ICD, Protecta VR ICD, and Protecta XT ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S684
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-09-05
- Decision code
- OK30
- Date received
- 2018-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the Titan Device Level Final Functional Tester for the Protecta family devices.