Tack Endovascular System (4F, 1.5-4.5mm)
FDA premarket approval P190027/S002 · decided 2021-10-08
Approval details
- PMA number
- P190027
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tack Endovascular System (4F, 1.5-4.5mm)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- Date received
- 2021-09-08
- Decision date
- 2021-10-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Alternate supplier for the tip component of the delivery system.
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