NOVOSTE(TM) BETA-CATH SYSTEM
FDA premarket approval P000018/S023 · decided 2002-07-31
Approval details
- PMA number
- P000018
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVOSTE(TM) BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2002-07-18
- Decision date
- 2002-07-31
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS TO IMPLEMENT A NEW PROCESS OF APPLYING THE O-RINGS TO THE PROPRIETARY CONNECTOR USING AN O-RING INSTALLATION TOOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.