Tack Endovascular System (4F)
FDA premarket approval P190027/S003 · decided 2022-09-29
Approval details
- PMA number
- P190027
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tack Endovascular System (4F)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- Date received
- 2022-01-11
- Decision date
- 2022-09-29
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for an alternate supplier for the delivery system.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.