KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8.
FDA premarket approval P980035/S280 · decided 2013-03-13
Approval details
- PMA number
- P980035
- Supplement
- S280
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8.
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2012-07-17
- Decision date
- 2013-03-13
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPA 900, ADAPTA, SENSIA, RELIA, ENPULSE, ENRHYTHM, ADVISA, VERSA AND SIGMA.
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