PMA P820034S005

Device: REPRO-MED - THD
Applicant: Repro-Med Systems, Inc.
PMA number: P820034
Supplement: S005
Product code: LOA
Decision date: 1997-01-14
Generic name: DEVICE, TESTICULAR HYPOTHERMIA
Approval order statement: APPROVAL TO MOVE THE MANUFACTURING SITE LOCATED AT REPRO-MED SYSTEMS, MIDDLETOWN, NY TO REPRO-MED SYSTEMS, 24 CARPENTER RD., CHESTER, NY. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE 20-MAR-96 "DEAR PRESIDENT OR CEO" LETTER RE: CHANGES IN MANUFACTURING SITES.

Current openFDA PMA Record#

Device: REPRO-MED - THD
Applicant: Repro-Med Systems, Inc.
PMA number: P820034
Supplement: S005
Product code: LOA
Generic name: DEVICE, TESTICULAR HYPOTHERMIA
Decision date: 1997-01-14
Decision code: APPR
Date received: 1996-12-12
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO MOVE THE MANUFACTURING SITE LOCATED AT REPRO-MED SYSTEMS, MIDDLETOWN, NY TO REPRO-MED SYSTEMS, 24 CARPENTER RD., CHESTER, NY. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE 20-MAR-96 "DEAR PRESIDENT OR CEO" LETTER RE: CHANGES IN MANUFACTURING SITES.