PMA P990001S106
- Device
- VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S106
- Product code
- NVZ
- Decision date
- 2012-08-20
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
Current openFDA PMA Record
- Device
- VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S106
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-08-20
- Decision code
- OK30
- Date received
- 2012-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.