PMA P790005S061
- Device
- EBI OsteoGen Implantable Bone Growth Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790005
- Supplement
- S061
- Product code
- LOE
- Decision date
- 2018-04-26
- Classification
- Stimulator, Invasive Bone Growth
- Generic name
- Stimulator, invasive bone growth
- Approval order statement
- Qualification and implementation of digitally-controlled vacuum sealing equipment to replace the analog vacuum sealing equipment.
Current openFDA PMA Record#
- Device
- EBI OsteoGen Implantable Bone Growth Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790005
- Supplement
- S061
- Product code
- LOE
- Generic name
- Stimulator, invasive bone growth
- Decision date
- 2018-04-26
- Decision code
- OK30
- Date received
- 2018-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification and implementation of digitally-controlled vacuum sealing equipment to replace the analog vacuum sealing equipment.