PMA P040043S063
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S063
- Product code
- MIH
- Decision date
- 2014-07-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S063
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-07-02
- Decision code
- OK30
- Date received
- 2014-06-04
- Supplement type
- 30-Day Notice
- Approval order statement
- IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.