PMA P980035S627
- Device
- Adapta, Versa,Sensia IPG,Advisa DR IPG,Advisa DR MRI IPG,Advisa SR MRI IPG,Astra S DR MRI IPG,Astra S SR MRI IPG,Astra X
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S627
- Product code
- NVZ
- Decision date
- 2020-06-08
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Modify final visual inspection requirements for hybrid modules.
Current openFDA PMA Record#
- Device
- Adapta, Versa,Sensia IPG,Advisa DR IPG,Advisa DR MRI IPG,Advisa SR MRI IPG,Astra S DR MRI IPG,Astra S SR MRI IPG,Astra X
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S627
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-06-08
- Decision code
- OK30
- Date received
- 2020-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify final visual inspection requirements for hybrid modules.