PMA P960043S115
- Device
- Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S115
- Product code
- MGB
- Decision date
- 2021-10-27
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Modification to the grit blasting process on the push mandrel component of the Perclose ProStyle device.
Current openFDA PMA Record#
- Device
- Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S115
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-10-27
- Decision code
- OK30
- Date received
- 2021-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the grit blasting process on the push mandrel component of the Perclose ProStyle device.