ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S015 · decided 2011-06-17
Approval details
- PMA number
- P880047
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABSORBABLE ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2011-04-18
- Decision date
- 2011-06-17
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR A LARGER INTERCEED PRODUCT THAT MEASURES 5¿X6¿ IN SIZE. THE DEVICE, AS MODIFIED, IS INDICATED AS AN ADJUVANT IN OPEN (LAPAROTOMY) GYNECOLOGIC PELVIC SURGERY FOR REDUCING THE INCIDENCE OF POSTOPERATIVE PELVIC ADHESIONS AFTER METICULOUS HEMOSTASIS IS ACHIEVED.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.