PMA P910001S048

Device
ELCA CORONARY ATHERECTOMY CATHETERS
Applicant
Spectranetics Corp.
PMA number
P910001
Supplement
S048
Product code
LPC
Decision date
2011-06-08
Classification
Device, Angioplasty, Laser, Coronary
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement
ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT.

Current openFDA PMA Record#

Device
ELCA CORONARY ATHERECTOMY CATHETERS
Applicant
Spectranetics Corp.
PMA number
P910001
Supplement
S048
Product code
LPC
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date
2011-06-08
Decision code
OK30
Date received
2011-05-10
Supplement type
30-Day Notice
Approval order statement
ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT.