GUIDANT ZOOM PROGRAMMER
FDA premarket approval P910077/S055 · decided 2005-12-20
Approval details
- PMA number
- P910077
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GUIDANT ZOOM PROGRAMMER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-10-31
- Decision date
- 2005-12-20
- Days to decision
- 50 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 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
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