PMA P130030S066
- Device
- REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S066
- Product code
- MAF
- Decision date
- 2020-03-02
- Generic name
- STENT, CORONARY
- Approval order statement
- Update final stent cleaning equipment and process.
Current openFDA PMA Record#
- Device
- REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S066
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2020-03-02
- Decision code
- OK30
- Date received
- 2020-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update final stent cleaning equipment and process.