MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
FDA premarket approval P180025/S010 · decided 2023-10-11
Approval details
- PMA number
- P180025
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
- Generic name
- Device, hemostasis, vascular
- Applicant
- Teleflex Medical, LLC
- Date received
- 2023-01-13
- Decision date
- 2023-10-11
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Morrisville, NC
- Statement
- Approval for an additional manufacturing site in Tecate, Mexico and an additional sterilization site (Sterigenics West Memphis, AR facility) for the subject device.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (K261988) | Teleflex Medical, LLC | 2026-07-09 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |