PMA P990001S117
- Device
- VITA ENHANCR II
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S117
- Product code
- NVZ
- Decision date
- 2014-03-12
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
Current openFDA PMA Record
- Device
- VITA ENHANCR II
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S117
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2014-03-12
- Decision code
- OK30
- Date received
- 2014-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.