PMA P980033S043
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S043
- Product code
- QKJ
- Decision date
- 2015-08-12
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.
Current openFDA PMA Record#
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S043
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2015-08-12
- Decision code
- APPR
- Date received
- 2015-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.