CONTAK CD/EASYTRACK CRT-D SYSTEM
FDA premarket approval P010012/S265 · decided 2011-05-17
Approval details
- PMA number
- P010012
- Supplement
- S265
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTAK CD/EASYTRACK CRT-D SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2011-03-18
- Decision date
- 2011-05-17
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
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