KAPPA 706 SR IPG
FDA premarket approval P980035/S007 · decided 2000-05-11
Approval details
- PMA number
- P980035
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAPPA 706 SR IPG
- Applicant
- Medtronic, Inc.
- Date received
- 2000-04-10
- Decision date
- 2000-05-11
- Days to decision
- 31 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a modification to header part number 149422 for use with the Kappa SR Model 706.
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