KAPPA, ENPULSE, ADAPTA, SENSIA AND VERSA PACEMAKERS
FDA premarket approval P980035/S063 · decided 2006-11-15
Approval details
- PMA number
- P980035
- Supplement
- S063
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAPPA, ENPULSE, ADAPTA, SENSIA AND VERSA PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-10-13
- Decision date
- 2006-11-15
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 241 DDMA SOFTWARE.
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