STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA premarket approval P050007/S033 · decided 2015-10-09
Approval details
- PMA number
- P050007
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2015-02-25
- Decision date
- 2015-10-09
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., IN TIPPERARY IRELAND, AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |