PMA P980050S126
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S126
- Product code
- LWS
- Decision date
- 2020-06-02
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a change to the lead serial number ink/foil material for select implantable leads.
Current openFDA PMA Record#
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S126
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-06-02
- Decision code
- APPR
- Date received
- 2020-03-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the lead serial number ink/foil material for select implantable leads.