QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S005 · decided 2003-03-12
Approval details
- PMA number
- P010049
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2003-02-21
- Decision date
- 2003-03-12
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL FOR TWO LABELING ADDITIONS TO THE APPROVED PREMARKET APPROVAL APPLICATION.
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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 |