FDA.reportPublic FDA data

PMA P960043S105

Device
Perclose ProGlide Suture-Mediated Closure System
Applicant
Abbott Vascular, Inc.
PMA number
P960043
Supplement
S105
Product code
MGB
Decision date
2019-07-30
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Duplication of a manufacturing line for the Perclose ProGlide Suture-Mediated Closure System and expansion of a cleanroom within the existing approved manufacturing facility.

Current openFDA PMA Record#

Device
Perclose ProGlide Suture-Mediated Closure System
Applicant
Abbott Vascular, Inc.
PMA number
P960043
Supplement
S105
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2019-07-30
Decision code
OK30
Date received
2019-07-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Duplication of a manufacturing line for the Perclose ProGlide Suture-Mediated Closure System and expansion of a cleanroom within the existing approved manufacturing facility.