PMA P180034
- Device
- Tack Endovascular System (6F)
- Applicant
- Philips Image Guided Therapy Corporation
- PMA number
- P180034
- Supplement
- S007
- Product code
- QCT
- Decision date
- 2022-09-29
- Generic name
- Scaffold, dissection repair
- Approval order statement
- Approval for an alternate supplier for the delivery system.
Current openFDA PMA Record#
- Device
- Tack Endovascular System (6F)
- Applicant
- Philips Image Guided Therapy Corporation
- PMA number
- P180034
- Supplement
- S006
- Product code
- QCT
- Generic name
- Scaffold, dissection repair
- Decision date
- 2022-09-29
- Decision code
- APPR
- Date received
- 2022-01-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate supplier for the delivery system.