FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Catheter, Balloon, Transcervical
PMA: P970021
·
Supplement: S007
·
Decision Mar 27, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Catheter, Balloon, Transcervical
- Trade Name
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- PMA Number
- P970021
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- MKN
- Generic Name
- Catheter, balloon, transcervical
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 27, 2003
- Date Received
- January 13, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY.
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 |
|---|---|---|---|
| MKN | Catheter, Balloon, Transcervical | FDA class 3 | Unknown |