- Device
- Perclose ProGlide Suture-Mediated Closure System/Prostar XL Percutaneous Vascular Surgical System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S102
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-02-21
- Decision code
- APPR
- Date received
- 2018-11-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization site located at Sterigenics UK Limited Cotes Park Lane Somercotes, Alfreton DE55 4NJ United Kingdom.