MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW
FDA premarket approval P910031/S024 · decided 2007-06-22
Approval details
- PMA number
- P910031
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 2007-05-04
- Decision date
- 2007-06-22
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, GERMANY GMBH, WIESBADEN, GERMANY.
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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 |