PMA P970012S026
- Device
- KAPPA 400 MEDTRONIC IMPLANTABLE PULSE GENERATORS
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S026
- Product code
- NVZ
- Decision date
- 2006-12-21
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGES IN THE MANUFACTURING FLOW FOR THE FINAL DEVICE ASSEMBLY FOR IMPLANTABLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- KAPPA 400 MEDTRONIC IMPLANTABLE PULSE GENERATORS
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S026
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2006-12-21
- Decision code
- OK30
- Date received
- 2006-11-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN THE MANUFACTURING FLOW FOR THE FINAL DEVICE ASSEMBLY FOR IMPLANTABLE PULSE GENERATORS.