PMA P150003S070
- Device
- SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S070
- Product code
- NIQ
- Decision date
- 2021-03-05
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the incoming verification of the active pharmaceutical ingredient.
Current openFDA PMA Record#
- Device
- SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S070
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-03-05
- Decision code
- OK30
- Date received
- 2021-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the incoming verification of the active pharmaceutical ingredient.