PMA P790018S043
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S043
- Product code
- LWQ
- Decision date
- 2002-04-09
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S043
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2002-04-09
- Decision code
- APPR
- Date received
- 2002-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.