SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL
FDA premarket approval P960006/S025 · decided 2010-01-12
Approval details
- PMA number
- P960006
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2009-12-16
- Decision date
- 2010-01-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
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