PMA P980016S055
- Device
- MEDTRONIC MODEL 9996 AND MODEL 9997
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S055
- Product code
- LWS
- Decision date
- 2005-11-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MEDTRONIC MODEL 9996 AND MODEL 9997 APPLICATION SOFTWARE VERSION 2.0 USED WITH INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 ICD SYSTEM.
Current openFDA PMA Record#
- Device
- MEDTRONIC MODEL 9996 AND MODEL 9997
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S055
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-11-15
- Decision code
- APPR
- Date received
- 2005-09-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MEDTRONIC MODEL 9996 AND MODEL 9997 APPLICATION SOFTWARE VERSION 2.0 USED WITH INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 ICD SYSTEM.