PMA P980050S146
- Device
- Transvene CS/SVC Lead (6937A)
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S146
- Product code
- LWS
- Decision date
- 2026-04-15
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly
Current openFDA PMA Record#
- Device
- Transvene CS/SVC Lead (6937A)
- Applicant
- Medtronic, Inc.
- PMA number
- P980050
- Supplement
- S146
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-15
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly