ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS
FDA premarket approval P980035/S119 · decided 2008-11-25
Approval details
- PMA number
- P980035
- Supplement
- S119
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2008-10-27
- Decision date
- 2008-11-25
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE FOR THE L174 HALL SENSOR COMPONENT USED IN THE MEDTRONIC ADAPTA, VERSA AND SENSIA FAMILY OF PACEMAKERS.
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