BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)
FDA premarket approval P010003/S003 · decided 2004-05-03
Approval details
- PMA number
- P010003
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)
- Generic name
- Glue, surgical, arteries
- Applicant
- Cryolife, Inc.
- Date received
- 2004-03-17
- Decision date
- 2004-05-03
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- MUQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR A DISPOSABLE DUAL-BARREL PISTON-DRIVEN SYRINGE DISPENSING SYSTEM AS AN ALTERNATE TO THE CURRENT DUAL-BARREL REUSABLE RATCHETING PISTON-DRIVEN CARTRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BG3500 AND IS INDICATED FOR USE AS AN ADJUNCT TO STANDARD METHODS OF ACHIEVING HEMOSTASIS (SUCH AS SUTURES AND STAPLES) IN ADULT PATIENTS IN OPEN SURGICAL REPAIR OF LARGE VESSELS (SUCH AS AORTA, FEMORAL, AND CAROTID ARTERIES).
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