PMA P990001S116
- Device
- VITA ENHANCR II
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S116
- Product code
- NVZ
- Decision date
- 2014-01-16
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
Current openFDA PMA Record
- Device
- VITA ENHANCR II
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S116
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2014-01-16
- Decision code
- OK30
- Date received
- 2013-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.