PMA P790005S053
- Device
- EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790005
- Supplement
- S053
- Product code
- LOE
- Decision date
- 2015-12-17
- Generic name
- Stimulator, invasive bone growth
- Approval order statement
- QUALIFY AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790005
- Supplement
- S053
- Product code
- LOE
- Generic name
- Stimulator, invasive bone growth
- Decision date
- 2015-12-17
- Decision code
- OK30
- Date received
- 2015-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QUALIFY AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE DEVICE.