PMA P850022S026

Device: BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S026
Product code: LOF
Decision date: 2015-11-06
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
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: BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S026
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
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.