PMA P960043S126
- Device
- Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S126
- Product code
- MGB
- Decision date
- 2025-02-24
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- outsourcing of the manufacturing process of selected subassemblies
Current openFDA PMA Record#
- Device
- Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S126
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-02-24
- Decision code
- OK30
- Date received
- 2025-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- outsourcing of the manufacturing process of selected subassemblies