Closer Vascular Sealing System
FDA premarket approval P150022/S004 · decided 2018-02-07
Approval details
- PMA number
- P150022
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Closer Vascular Sealing System
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2018-01-08
- Decision date
- 2018-02-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval to modify the magnetic resonance imaging safety labeling.
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| 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 |
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