INDERMIL TISSUE ADHESIVE

FDA premarket approval P010002/S002 · decided 2002-06-28

Approval details

PMA number

P010002

Supplement

S002

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

INDERMIL TISSUE ADHESIVE

Generic name

Tissue adhesive for the topical approximation of skin

Applicant

Covidien Lp, Formerly Registered AS United States

Date received

2002-05-29

Decision date

2002-06-28

Days to decision

30 days

Decision code

OK30

Product code

MPN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Norwalk, CT

Statement

PACKAGING CHANGE FROM A 5 AND 20 UNIT DOSE CONFIGURATION TO A NEW 12 AND 24 UNIT DOSE CONFIGURATION. THE PACKAGING CHANGES WILL MAKE GREATER USE OF THE SPACE WITHIN THE PACKAGING AND ALLOW MORE UNITS TO BE SHIPPED IN THE SAME OR SLIGHTLY INCREASED VOLUME PACKAGING.

510(k) clearances by this applicant