PMA N12159S017

Device: SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S017
Product code: LMG
Decision date: 1999-05-05
Classification: Agent, Absorbable Hemostatic, Non-collagen Based
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for an additional location for the 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: SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S017
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-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 the 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.