PMA P830079S012

Device: INSTAT COLLAGEN ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S012
Product code: LMF
Decision date: 1999-05-05
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Approval for an additional location for final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754.

Current openFDA PMA Record#

Device: INSTAT COLLAGEN ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S012
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 1999-05-05
Decision code: APPR
Date received: 1998-08-28
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional location for final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754.