PMA P890043S034

Device: SIMPSON CORONARY ATHEROCATH-GTO
Applicant: Abbott Vascular
PMA number: P890043
Supplement: S034
Product code: MCX
Decision date: 1999-10-12
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.

Current openFDA PMA Record

Device: SIMPSON CORONARY ATHEROCATH-GTO
Applicant: Abbott Vascular
PMA number: P890043
Supplement: S034
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 1999-10-12
Decision code: OK30
Date received: 1999-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.