PMA P970012S040
- Device
- KAPPA 400 DR/SR
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S040
- Product code
- NVZ
- Decision date
- 2008-12-24
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- KAPPA 400 DR/SR
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S040
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2008-12-24
- Decision code
- APPR
- Date received
- 2008-08-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.