FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
FDA premarket approval P910031/S011 · decided 1997-04-09
Approval details
- PMA number
- P910031
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 1996-08-26
- Decision date
- 1997-04-09
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25
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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 |