INFUSAID IMPLANTABLE INFUSION PUMP
FDA premarket approval P800036/S031 · decided 1996-12-23
Approval details
- PMA number
- P800036
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSAID IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1994-03-08
- Decision date
- 1996-12-23
- Days to decision
- 1021 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- APPROVAL FOR THE UNFUSAID(TM) 14G INTRASPINAL CATHETER KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.