PMA P130030S075
- Device
- REBEL Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S075
- Product code
- MAF
- Decision date
- 2023-03-02
- Classification
- Cardiovascular
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for the introduction of an alternative resin material (ReZilok Rx 101) supplied by existing BSC-approved supplier Compounding Solutions.
Current openFDA PMA Record#
- Device
- REBEL Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S075
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2023-03-02
- Decision code
- APPR
- Date received
- 2022-12-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the introduction of an alternative resin material (ReZilok Rx 101) supplied by existing BSC-approved supplier Compounding Solutions.