- Device
- MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
- Applicant
- Davis & Geck, Inc.
- PMA number
- P840051
- Supplement
- S007
- Product code
- GAM
- Generic name
- Suture, absorbable, synthetic, polyglycolic acid
- Decision date
- 1996-01-11
- Decision code
- APPR
- Date received
- 1995-12-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED