ADDITION OF ALTERNATE TUBING EXTRUDER
FDA premarket approval P960004/S002 · decided 1997-10-23
Approval details
- PMA number
- P960004
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADDITION OF ALTERNATE TUBING EXTRUDER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1997-04-17
- Decision date
- 1997-10-23
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the use of an alternate tubing extrusion process for the Pellethane(R) 55D used in the ThinLine(TM) family of pacing leads.
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