FDA.reportPublic FDA data

PMA P050018S026

Device
AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX)
Applicant
Spectranetics Corp.
Product code
NWX
Decision date
2020-09-11
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Approval order statement
Approval for various design changes, including additional coating to the transition tube and modifications to the balloon, distal tip, and scoring element.

Current openFDA PMA Record#

Device
AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX)
Applicant
Spectranetics Corp.
PMA number
P050018
Supplement
S026
Product code
NWX
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Decision date
2020-09-11
Decision code
APPR
Date received
2019-07-09
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for various design changes, including additional coating to the transition tube and modifications to the balloon, distal tip, and scoring element.