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THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
GYNECARE, INC.
Trade Name
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
Generic Name
Device, thermal ablation, endometrial
Decision Date
12/12/1997
Days to Decision
178 days
Decision Code
APWD
FDA Decision
Withdrawal after approval

THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
GYNECARE, INC.
Trade Name
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
Generic Name
Device, thermal ablation, endometrial
Decision Date
12/12/1997
Days to Decision
178 days
Decision Code
APWD
FDA Decision
Withdrawal after approval