PMA P910001S028

Device
ANGIOPLASTY/LASER/CORONARY DEVICE
Applicant
Spectranetics Corp.
PMA number
P910001
Supplement
S028
Product code
LPC
Decision date
2008-12-11
Classification
Device, Angioplasty, Laser, Coronary
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement
CHANGE TO AN IN-PROCESS MANUFACTURING AID.

Current openFDA PMA Record#

Device
ANGIOPLASTY/LASER/CORONARY DEVICE
Applicant
Spectranetics Corp.
PMA number
P910001
Supplement
S028
Product code
LPC
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date
2008-12-11
Decision code
OK30
Date received
2008-11-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO AN IN-PROCESS MANUFACTURING AID.