PMA P000037S037
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S037
- Product code
- LWQ
- Decision date
- 2015-02-09
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR MODIFIED DEVICE PACKAGING AND AN EXTENSION TO THE PRODUCT SHELF LIFE.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S037
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2015-02-09
- Decision code
- APPR
- Date received
- 2014-08-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFIED DEVICE PACKAGING AND AN EXTENSION TO THE PRODUCT SHELF LIFE.