PMA P850035S053

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S053
Product code: LOE
Decision date: 2018-05-07
Classification: Stimulator, Invasive Bone Growth
Generic name: Stimulator, invasive bone growth
Approval order statement: Qualify and implement redesigned, manufacturing, work area layouts, installation of a new environmental monitoring (HEMS) system and complementary clean room equipment within the ISO Class 8 Environmentally Controlled Clean Room Area (CEA) and its corresponding ISO Class 8 Adjacent Gowning Room at Guaynabo, Puerto Rico Manufacturing and Distribution Facility.

Current openFDA PMA Record#

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S053
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2018-05-07
Decision code: OK30
Date received: 2018-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualify and implement redesigned, manufacturing, work area layouts, installation of a new environmental monitoring (HEMS) system and complementary clean room equipment within the ISO Class 8 Environmentally Controlled Clean Room Area (CEA) and its corresponding ISO Class 8 Adjacent Gowning Room at Guaynabo, Puerto Rico Manufacturing and Distribution Facility.