PMA P900056S010

Device
ROTABLATOR(R)
Applicant
Boston Scientific Corp
PMA number
P900056
Supplement
S010
Product code
MCX
Decision date
1995-04-27
Classification
Catheter, Coronary, Atherectomy
Generic name
CATHETER, CORONARY, ATHERECTOMY

Current openFDA PMA Record#

Device
ROTABLATOR(R)
Applicant
Boston Scientific Corp
PMA number
P900056
Supplement
S010
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
1995-04-27
Decision code
APPR
Date received
1995-03-07
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename