PMA P990001S057
- Device
- C-SERIES IPG DEVICES, T-SERIES IPG DEVICES DEMA FAMILY
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S057
- Product code
- NVZ
- Decision date
- 2010-01-21
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
Current openFDA PMA Record
- Device
- C-SERIES IPG DEVICES, T-SERIES IPG DEVICES DEMA FAMILY
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S057
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-01-21
- Decision code
- APPR
- Date received
- 2009-10-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.