PMA P960043S129
- Device
- Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S129
- Product code
- MGB
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- refinement of adhesive application during the guide subassembly process
Current openFDA PMA Record#
- Device
- Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S129
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- refinement of adhesive application during the guide subassembly process