PMA P980033S012
- Device
- WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S012
- Product code
- QKJ
- Decision date
- 2005-01-14
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S012
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2005-01-14
- Decision code
- OK30
- Date received
- 2004-12-20
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.