PRIZM FAMILY
FDA premarket approval P960040/S075 · decided 2005-11-24
Approval details
- PMA number
- P960040
- Supplement
- S075
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRIZM FAMILY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-15
- Decision date
- 2005-11-24
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF FOUR NEW INNER LEAD BONDING (ILB) MACHINES ON THE TAPE AUTOMATED BONDING (TAB) MANUFACTURING LINE FOR PULSE GENERATORS.
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