GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S028 · decided 2019-01-10
Approval details
- PMA number
- P880047
- Supplement
- S028
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE INTERCEED Absorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2018-12-07
- Decision date
- 2019-01-10
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for endotoxin testing and limit requirements for GYNECARE INTERCEED® Absorbable Adhesion Barrier manufactured at the San Lorenzo, Puerto Rico and Neuchatel Switzerland sites.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.