PMA P970012S060
- Device
- KAPPA 400 DR/SR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S060
- Product code
- NVZ
- Decision date
- 2010-01-06
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
Current openFDA PMA Record#
- Device
- KAPPA 400 DR/SR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S060
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-01-06
- Decision code
- OK30
- Date received
- 2009-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- RELOCATION OF AN ETHYLENE OXIDE STERILIZER.