PMA P940019S050

Device
Wallstent Lilac Endoprosthesis With Unistep Plus Delivery System
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S050
Product code
NIO
Decision date
2017-06-28
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
Use of updated equipment for a subassembly process.

Current openFDA PMA Record#

Device
Wallstent Lilac Endoprosthesis With Unistep Plus Delivery System
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S050
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2017-06-28
Decision code
OK30
Date received
2017-06-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of updated equipment for a subassembly process.