PMA P980016S259
- Device
- MARQUIS/MAXIMO/INTRINSIC ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S259
- Product code
- LWS
- Decision date
- 2010-10-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE TO THE EFTE COATING INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- MARQUIS/MAXIMO/INTRINSIC ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S259
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2010-10-15
- Decision code
- OK30
- Date received
- 2010-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE EFTE COATING INSPECTION PROCESS.