PMA P190027S002
- Device
- Tack Endovascular System (4F, 1.5-4.5mm)
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- PMA number
- P190027
- Supplement
- S002
- Product code
- QCT
- Decision date
- 2021-10-08
- Generic name
- Scaffold, dissection repair
- Approval order statement
- Alternate supplier for the tip component of the delivery system.
Current openFDA PMA Record#
- Device
- Tack Endovascular System (4F, 1.5-4.5mm)
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- PMA number
- P190027
- Supplement
- S002
- Product code
- QCT
- Generic name
- Scaffold, dissection repair
- Decision date
- 2021-10-08
- Decision code
- OK30
- Date received
- 2021-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the tip component of the delivery system.