MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
FDA premarket approval P910031/S023 · decided 2006-02-16
Approval details
- PMA number
- P910031
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 2004-11-16
- Decision date
- 2006-02-16
- Days to decision
- 457 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW). THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EX
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |