- Device
- CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S072
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-11-10
- Decision code
- APPR
- Date received
- 2010-06-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.