PMA P910077S048
- Device
- HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S048
- Product code
- LWS
- Decision date
- 2005-03-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1 WHICH IS INDICATED FOR INTERROGATING AND DOWNLOADING DIAGNOSTIC INFORMATION OBTAINED BY GUIDANT'S PACEMAKER AND DEFIBRILLATOR CARDIAC RESYNCHRONIZATION THERAPY (CRT-P AND CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S048
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-03-02
- Decision code
- APPR
- Date received
- 2004-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1 WHICH IS INDICATED FOR INTERROGATING AND DOWNLOADING DIAGNOSTIC INFORMATION OBTAINED BY GUIDANT'S PACEMAKER AND DEFIBRILLATOR CARDIAC RESYNCHRONIZATION THERAPY (CRT-P AND CRT-D DEVICES.