CONTAK CD/EASYTRACK CRT SYSTEM
FDA premarket approval P010012/S155 · decided 2007-12-20
Approval details
- PMA number
- P010012
- Supplement
- S155
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTAK CD/EASYTRACK CRT SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2007-08-23
- Decision date
- 2007-12-20
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
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