PMA P130030S072
- Device
- REBEL Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S072
- Product code
- MAF
- Decision date
- 2021-03-24
- Generic name
- STENT, CORONARY
- Approval order statement
- Update the acceptance criteria for the population of white phase precipitate present in platinum chromium alloys (PCA) tubing.
Current openFDA PMA Record#
- Device
- REBEL Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S072
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the acceptance criteria for the population of white phase precipitate present in platinum chromium alloys (PCA) tubing.