SMARTVIEW
FDA premarket approval P950029/S034 · decided 2008-03-18
Approval details
- PMA number
- P950029
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SMARTVIEW
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-03-05
- Decision date
- 2008-03-18
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE.
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