Gynecare Interceed Absorbable Adhesion Barrier
FDA premarket approval P880047/S027 · decided 2017-07-06
Approval details
- PMA number
- P880047
- Supplement
- S027
- 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
- 2017-06-12
- Decision date
- 2017-07-06
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Adding an automated label scanning system verify the batch information and packaging components for product codes 435050 and 194350 at Ethicon SARL, Neuchâtel Switzerland.
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