PMA P090029S020

Device: Prestige LP (R) Cervical Disc
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S020
Product code: MJO
Decision date: 2024-05-01
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: a change of the film adhesive used in tensile testing of the titanium plasma spray coating and a change in material for the masking/fixturing in the titanium sprayed coating process of the PRESTIGE LP® Cervical Disc

Current openFDA PMA Record#

Device: Prestige LP (R) Cervical Disc
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S020
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2024-05-01
Decision code: OK30
Date received: 2024-04-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change of the film adhesive used in tensile testing of the titanium plasma spray coating and a change in material for the masking/fixturing in the titanium sprayed coating process of the PRESTIGE LP® Cervical Disc