PMA P990064S002

Device: MOSAIC PORCINE BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P990064
Supplement: S002
Decision date: 2000-08-29
Approval order statement: CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS. ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS. THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.

Current openFDA PMA Record#

Device: MOSAIC PORCINE BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P990064
Supplement: S002
Decision date: 2000-08-29
Decision code: OK30
Date received: 2000-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS. ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS. THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.