- Device
- SYNERGY MEGATRON™ Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S143
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2024-07-26
- Decision code
- OK30
- Date received
- 2024-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of inners assembly for the stent delivery system