PMA P900056S144
- Device
- ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S144
- Product code
- MCX
- Decision date
- 2015-05-12
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL TO UPDATE INSPECTION REQUIREMENTS AT THE BSC CORK, IRELAND SITE.
Current openFDA PMA Record#
- Device
- ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S144
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2015-05-12
- Decision code
- APPR
- Date received
- 2014-12-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO UPDATE INSPECTION REQUIREMENTS AT THE BSC CORK, IRELAND SITE.