KAPPA 400 IPG
FDA premarket approval P970012/S088 · decided 2011-08-04
Approval details
- PMA number
- P970012
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KAPPA 400 IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2011-07-06
- Decision date
- 2011-08-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
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