PMA P980016S349
- Device
- CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S349
- Product code
- LWS
- Decision date
- 2012-05-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- UPDATE TO THE VENDOR INSPECTION PROCESS FOR FLEX COMPONENT.
Current openFDA PMA Record#
- Device
- CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S349
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-05-10
- Decision code
- OK30
- Date received
- 2012-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE TO THE VENDOR INSPECTION PROCESS FOR FLEX COMPONENT.