MANTA Vascular Closure Device
FDA premarket approval P180025/S005 · decided 2019-08-06
Approval details
- PMA number
- P180025
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MANTA Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Teleflex Medical, LLC
- Date received
- 2019-07-23
- Decision date
- 2019-08-06
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Morrisville, NC
- Statement
- Reduce the number of in-process inspections for pouch seal strength testing.
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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 |