GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S031 · decided 2019-04-12
Approval details
- PMA number
- P880047
- Supplement
- S031
- Supplement type
- 30-Day Notice
- 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
- 2019-03-14
- Decision date
- 2019-04-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Extension of the Clean Manufacturing Environment at the Ethicon SARL, Neuchatel Switzerland site.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.