GYNECARE INTECEED Adhesion Barrier
FDA premarket approval P880047/S039 · decided 2021-04-01
Approval details
- PMA number
- P880047
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE INTECEED Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2021-03-03
- Decision date
- 2021-04-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Change of ink used for the inline printing on GYNECARE INTERCEED product cartons at Ethicon SARL in Neuchatel, Switzerland.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.