FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Device, Testicular Hypothermia
PMA: P820034
·
Supplement: S005
·
Decision Jan 14, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Device, Testicular Hypothermia
- Trade Name
- REPRO-MED - THD
- PMA Number
- P820034
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LOA
- Generic Name
- DEVICE, TESTICULAR HYPOTHERMIA
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 14, 1997
- Date Received
- December 12, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOA | Device, Testicular Hypothermia | FDA class 3 | Unknown |