FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P880047
·
Supplement: S067
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5.
- PMA Number
- P880047
- Supplement Number
- S067
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 9, 2025
- Date Received
- September 26, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a second automated packer used during the secondary packaging process
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 |
|---|---|---|---|
| MCN | Barrier, Absorbable, Adhesion | FDA class 3 | Unknown |