PMA P140018S030

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S030
Product code
PJQ
Decision date
2021-12-09
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Implementation of SAP Manufacturing Intelligence Integration (Mii) software for use in manufacturing of the VenaSeal Closure System.

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S030
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2021-12-09
Decision code
OK30
Date received
2021-11-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of SAP Manufacturing Intelligence Integration (Mii) software for use in manufacturing of the VenaSeal Closure System.