QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S009 · decided 2003-12-23
Approval details
- PMA number
- P010049
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2003-10-02
- Decision date
- 2003-12-23
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL TO REDUCE THE MINIMUM REQUIRED ACCESS SITE DEPTH FROM 3 CENTIMETERS TO 2 CENTIMETERS IN THE INSTRUCTIONS FOR USE.
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 |
|---|---|---|
| QS DELIVERY SYSTEM (K991254) | Sub-Q, Inc. | 1999-08-23 |
| IRRIGATION SYRINGE KIT (K982435) | Sub-Q, Inc. | 1998-11-06 |