PMA P050038S027
- Device
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S027
- Product code
- LMG
- Decision date
- 2015-12-02
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- CHANGES TO THE POLY/TYVEK POUCH PACKAGING USED IN BOTH ARISTA FLEXITIP XL AND FLEXITIP XL-R. THESE CHANGES INCLUDED 1) REVISION TO POUCH SEALING PARAMETERS 2) ADDITION OF APPEARANCE CRITERIA AND REVISED TOLERANCES TO MANUFACTURED POUCH, AND 3) IMPLEMENTATION OF A NEW SEALER FOR THE FLEXITIP XL POUCH.
Current openFDA PMA Record#
- Device
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S027
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2015-12-02
- Decision code
- OK30
- Date received
- 2015-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE POLY/TYVEK POUCH PACKAGING USED IN BOTH ARISTA FLEXITIP XL AND FLEXITIP XL-R. THESE CHANGES INCLUDED 1) REVISION TO POUCH SEALING PARAMETERS 2) ADDITION OF APPEARANCE CRITERIA AND REVISED TOLERANCES TO MANUFACTURED POUCH, AND 3) IMPLEMENTATION OF A NEW SEALER FOR THE FLEXITIP XL POUCH.