Closer Vascular Sealing System (VSS)
FDA premarket approval P150022/S007 · decided 2018-10-01
Approval details
- PMA number
- P150022
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Closer Vascular Sealing System (VSS)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2018-09-11
- Decision date
- 2018-10-01
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Addition of an alternate vendor for the tipping process.
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| Option (TM) ELITE Vena Cava Filter 100cm System (K143405) | Rex Medical, L.P. | 2015-04-16 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K141617) | Rex Medical, L.P. | 2014-11-14 |
| OPTION ELITE VENA CAVA FILTER SYSTEM (K133243) | Rex Medical, L.P. | 2013-12-17 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K060904) | Rex Medical, L.P. | 2006-04-28 |
| MODIFICATION TO SHORT INTRODUCER SHEATH (K042399) | Rex Medical, L.P. | 2004-12-17 |