PMA P960043S130
- Device
- Perclose ProGuide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S130
- Product code
- MGB
- Decision date
- 2026-02-11
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- relocation of guide subassembly station within existing manufacturing facility
Current openFDA PMA Record#
- Device
- Perclose ProGuide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S130
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocation of guide subassembly station within existing manufacturing facility