PMA P980035S652
- Device
- Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S652
- Product code
- NVZ
- Decision date
- 2020-10-08
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Implementation of battery height weld inspection.
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S652
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-10-08
- Decision code
- OK30
- Date received
- 2020-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of battery height weld inspection.