SLS SPECTRANETICS LASER SHEATHS
FDA premarket approval P960042/S037 · decided 2012-05-16
Approval details
- PMA number
- P960042
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SLS SPECTRANETICS LASER SHEATHS
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2012-04-10
- Decision date
- 2012-05-16
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR QUALIFYING THE USE OF LOCTITE 7701 AS A SUITABLE REPLACEMENT FOR THE DISCONTINUED LOCTITE 793.
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