PMA P980016S298
- Device
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S298
- Product code
- LWS
- Decision date
- 2011-08-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR DESIGN, MATERIALS, AND MANUFACTURING CHANGES TO THE HYBRIDS USED IN THE GEN2 AND ADAMS HYBRID PLATFORMS.
Current openFDA PMA Record#
- Device
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S298
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-08-18
- Decision code
- APPR
- Date received
- 2011-04-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN, MATERIALS, AND MANUFACTURING CHANGES TO THE HYBRIDS USED IN THE GEN2 AND ADAMS HYBRID PLATFORMS.