PMA P850035S040
- Device
- SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850035
- Supplement
- S040
- Product code
- LOE
- Decision date
- 2015-12-17
- Classification
- Stimulator, Invasive Bone Growth
- 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
- SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850035
- Supplement
- S040
- 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.