ALL NON-RATE RESPONSIVE PACEMAKERS
FDA premarket approval P900022/S009 · decided 2007-11-13
Approval details
- PMA number
- P900022
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALL NON-RATE RESPONSIVE PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2007-08-29
- Decision date
- 2007-11-13
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY).
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