KAPPA 400
FDA premarket approval P970012/S079 · decided 2010-12-13
Approval details
- PMA number
- P970012
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KAPPA 400
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-11-15
- Decision date
- 2010-12-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE MOLDS USED IN THE MANUFACTURE OF THE DEVICES AND THE ADDITION OF A SECOND SUPPLIER OF THESE MOLDS.
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