PMA P910031S024

Device: MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S024
Product code: LOX
Decision date: 2007-06-22
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, GERMANY GMBH, WIESBADEN, GERMANY.

Current openFDA PMA Record#

Device: MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S024
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2007-06-22
Decision code: APPR
Date received: 2007-05-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, GERMANY GMBH, WIESBADEN, GERMANY.