PMA P880047S057
- Device
- GYNECARE INTERCEED™ Absorbable Adhesion Barrier
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S057
- Product code
- MCN
- Decision date
- 2023-12-11
- Classification
- Obstetrics/Gynecology
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- inclusion of an additional oxidation reactor in the Janssen Pharmaceuticals, Inc., Athens, Georgia manufacturing facility
Current openFDA PMA Record#
- Device
- GYNECARE INTERCEED™ Absorbable Adhesion Barrier
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S057
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2023-12-11
- Decision code
- OK30
- Date received
- 2023-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- inclusion of an additional oxidation reactor in the Janssen Pharmaceuticals, Inc., Athens, Georgia manufacturing facility