PMA P980050S139
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S139
- Product code
- LWS
- Decision date
- 2022-11-22
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.
Current openFDA PMA Record#
- Device
- Transvene CS/SVC Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S139
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-11-22
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.