FDA.reportPublic FDA data

PMA P910001S112

Device
Spectranetics Laser Sheath (SLS)
Applicant
Spectranetics Corp.
Product code
LPC
Decision date
2021-09-02
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement
Approval for the next generation Philips Laser System (PLS), including compatibility with the ELCA coronary laser atherectomy catheter, Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.

Current openFDA PMA Record#

Device
Spectranetics Laser Sheath (SLS)
Applicant
Spectranetics Corp.
PMA number
P910001
Supplement
S112
Product code
LPC
Generic name
DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date
2021-09-02
Decision code
APPR
Date received
2021-01-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the next generation Philips Laser System (PLS), including compatibility with the ELCA coronary laser atherectomy catheter, Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.