PMA P980035S617
- Device
- Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S617
- Product code
- NVZ
- Decision date
- 2020-03-03
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Modify the seam weld inspection process.
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S617
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-03-03
- Decision code
- OK30
- Date received
- 2020-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the seam weld inspection process.