FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
FDA premarket approval P970052 · decided 1998-02-20
Approval details
- PMA number
- P970052
- Trade name
- FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Endologix, Inc.
- Date received
- 1997-11-04
- Decision date
- 1998-02-20
- Days to decision
- 108 days
- Decision code
- APWD
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the FACT(TM), ARC(TM), LYNX(TM) and Guardian(TM) Balloon Coronary Dilatation Catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purposed of improving myocardial perfusion. The application includes authorization from Endosoncis Corp., Rancho Cordova, CA, to incorporate information contained in its approved premarket approval application and related supplements for hte Cathscanner(R) Oracle(R) Mic
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AFX INTRODUCER SYSTEM (K120212) | Endologix, Inc. | 2012-02-09 |
| ENDOLOGIX AFX INTRODUCER SYSTEM (K111747) | Endologix, Inc. | 2011-07-12 |
| AFX INTRODUCER SYSTEM (K110090) | Endologix, Inc. | 2011-05-26 |
| ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (K080360) | Endologix, Inc. | 2008-04-08 |
| DUAL LUMEN CATHETER, MODEL DL-35-90 (K991601) | Endologix, Inc. | 1999-10-28 |