PMA P900056S212
- Device
- Rotablator Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S212
- Product code
- MCX
- Decision date
- 2023-12-12
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility
Current openFDA PMA Record#
- Device
- Rotablator Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S212
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2023-12-12
- Decision code
- OK30
- Date received
- 2023-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility