PMA P850035S039

Device: SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S039
Product code: LOE
Decision date: 2015-11-06
Classification: Stimulator, Invasive Bone Growth
Generic name: Stimulator, invasive bone growth
Approval order statement: IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.

Current openFDA PMA Record#

Device: SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S039
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2015-11-06
Decision code: OK30
Date received: 2015-10-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.