PMA P900056S136
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S136
- Product code
- MCX
- Decision date
- 2014-04-24
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- ADDITION OF AN ALTERNATE MICROBIOLOGY LABORATORY FOR THE TESTING OF BIOBURDEN FOR THE ROTAWIRE WITH WIRE CLIP TORQUER.
Current openFDA PMA Record#
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S136
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2014-04-24
- Decision code
- OK30
- Date received
- 2014-03-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE MICROBIOLOGY LABORATORY FOR THE TESTING OF BIOBURDEN FOR THE ROTAWIRE WITH WIRE CLIP TORQUER.