PMA P880047S067
- Device
- GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5.
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S067
- Product code
- MCN
- Decision date
- 2025-10-09
- Classification
- Obstetrics/Gynecology
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- a second automated packer used during the secondary packaging process
Current openFDA PMA Record#
- Device
- GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5.
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S067
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2025-10-09
- Decision code
- OK30
- Date received
- 2025-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a second automated packer used during the secondary packaging process