PMA P880047S041
- Device
- GYNECARE INTERCEED™ Absorbable Adhesion Barrier
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S041
- Product code
- MCN
- Decision date
- 2021-08-31
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- Expansion of the controlled manufacturing environment (CME) in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- GYNECARE INTERCEED™ Absorbable Adhesion Barrier
- Applicant
- ETHICON, Inc.
- PMA number
- P880047
- Supplement
- S041
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the controlled manufacturing environment (CME) in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.