StarClose SE Vascular Closure System
FDA premarket approval P050007/S042 · decided 2022-12-16
Approval details
- PMA number
- P050007
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- StarClose SE Vascular Closure System
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2022-11-16
- Decision date
- 2022-12-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454) | Abbott Vascular Devices | 2005-09-14 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |