PMA P990001S107
- Device
- VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S107
- Product code
- NVZ
- Decision date
- 2012-08-17
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
Current openFDA PMA Record
- Device
- VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S107
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-08-17
- Decision code
- OK30
- Date received
- 2012-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.