GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
FDA premarket approval P970052/S002 · decided 1998-05-19
Approval details
- PMA number
- P970052
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Endologix, Inc.
- Date received
- 1997-11-19
- Decision date
- 1998-05-19
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter.
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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 |