ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1
FDA premarket approval P950029/S041 · decided 2009-06-11
Approval details
- PMA number
- P950029
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-03-02
- Decision date
- 2009-06-11
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1.
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