PMA P830079S015

Device: INSTAT COLLAGEN HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S015
Product code: LMF
Decision date: 2004-06-22
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO; AND A LOWERED MINIMUM RADIATION STERILIZATION DOSE.

Current openFDA PMA Record#

Device: INSTAT COLLAGEN HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S015
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2004-06-22
Decision code: APPR
Date received: 2004-04-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO; AND A LOWERED MINIMUM RADIATION STERILIZATION DOSE.