HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1
FDA premarket approval P910077/S048 · decided 2005-03-02
Approval details
- PMA number
- P910077
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-11-19
- Decision date
- 2005-03-02
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.