PMA P900056S124
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S124
- Product code
- MCX
- Decision date
- 2013-07-10
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- CHANGE TO THE IN-PROCESS STRAIGHTNESS INSPECTION CRITERIA FOR THE ROTAWIREWHICH IS PART OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.
Current openFDA PMA Record#
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S124
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2013-07-10
- Decision code
- OK30
- Date received
- 2013-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE IN-PROCESS STRAIGHTNESS INSPECTION CRITERIA FOR THE ROTAWIREWHICH IS PART OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.