PMA N16374S036
- Device
- PRONOVA ABSORABLE SUTURE, USP
- Applicant
- ETHICON, INC.
- PMA number
- N16374
- Supplement
- S036
- Product code
- GATÂ
- Decision date
- 1999-06-24
- Generic name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Approval order statement
- Approval For The PRONOVA Non-absorbable Suture Manufactured From Poly (vinylidene Fluoride) And Poly (vinylidene Fluoride-co-hexafluoropropylene). The Device, As Modified, Will Be Marketed Under The Trade Name PRONOVA And Is Indicated For Use In General Soft Tissue Approximation And/or Ligation, Including Use In Cardiovascular, Ophthalmic And Neurological Procedures.
Current openFDA PMA Record
- Device
- PRONOVA ABSORABLE SUTURE, USP
- Applicant
- ETHICON, Inc.
- PMA number
- N16374
- Supplement
- S036
- Product code
- GAT
- Generic name
- Suture, nonabsorbable, synthetic, polyethylene
- Decision date
- 1999-06-24
- Decision code
- APPR
- Date received
- 1998-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the PRONOVA Non-absorbable Suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene). The device, as modified, will be marketed under the trade name PRONOVA and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.