PMA P790002S034
- Device
- BIOMET EBI BONE HEALING SYSTEM
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790002
- Supplement
- S034
- Product code
- LOF
- Decision date
- 2016-01-14
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
Current openFDA PMA Record#
- Device
- BIOMET EBI BONE HEALING SYSTEM
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790002
- Supplement
- S034
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2016-01-14
- Decision code
- OK30
- Date received
- 2015-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.