FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aspiration Therapy System
PMA: P150024
·
Supplement: S010
·
Decision Jan 15, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Aspiration Therapy System
- Trade Name
- AspireAssist
- PMA Number
- P150024
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- OYF
- Generic Name
- Aspiration therapy system
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 15, 2019
- Date Received
- May 1, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (PAS) protocol.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYF | Aspiration Therapy System | FDA class 3 | Unknown |