PMA P110005S015

Device: Gelsyn-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S015
Product code: MOZ
Decision date: 2026-07-24
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approved for the addition of a new dispensing area, Room A107, for the sampling and weighing of raw materials used in the manufacture of GELSYN-3™ (sodium hyaluronate 0.84%) at the IBSA Farmaceutici Italia Srl facility in San Grato-Lodi, Italy, under the same FEI as the currently approved dispensing area

Current openFDA PMA Record#

Device: Gelsyn-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S015
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2026-07-24
Decision code: OK30
Date received: 2026-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approved for the addition of a new dispensing area, Room A107, for the sampling and weighing of raw materials used in the manufacture of GELSYN-3™ (sodium hyaluronate 0.84%) at the IBSA Farmaceutici Italia Srl facility in San Grato-Lodi, Italy, under the same FEI as the currently approved dispensing area