PMA P980050S138
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S138
- Product code
- LWS
- Decision date
- 2022-06-01
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the FACTORYWorks Manufacturing Execution System to Release 9.10.
Current openFDA PMA Record#
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S138
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the FACTORYWorks Manufacturing Execution System to Release 9.10.