PMA P970012S033
- Device
- KAPPA 400 DR, KAPPA 400 SR
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S033
- Product code
- NVZ
- Decision date
- 2008-02-21
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
Current openFDA PMA Record#
- Device
- KAPPA 400 DR, KAPPA 400 SR
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S033
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2008-02-21
- Decision code
- OK30
- Date received
- 2008-01-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.