PMA P050044S029

Device: VITAGEL RT3 SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S029
Product code: LMF
Decision date: 2014-12-12
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE RELOCATION OF CERTAIN MANUFACTURING EQUIPMENT USED FOR ASSEMBLY AND PACKAGING OF VITAGEL RT3 SURGICAL HEMOSTAT FROM ONE ROOM TO ANOTHER ROOM WITHIN THE FIRMS MALVERN, PENNSYLVANIA FACILITY.

Current openFDA PMA Record#

Device: VITAGEL RT3 SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S029
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-12-12
Decision code: APPR
Date received: 2014-07-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE RELOCATION OF CERTAIN MANUFACTURING EQUIPMENT USED FOR ASSEMBLY AND PACKAGING OF VITAGEL RT3 SURGICAL HEMOSTAT FROM ONE ROOM TO ANOTHER ROOM WITHIN THE FIRMS MALVERN, PENNSYLVANIA FACILITY.